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Drug Approvals for March 1997
Definitions and Notes
Original New Drug Applications
Original Application #: 020570
Approval Date: 28-MAR-97
Trade Name: QUADRAMET
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: CYTOGEN CORP
Active Ingredient(s): SAMARIUM SM 153 EDTMP
OTC/RX Status: RX
Indication(s): For relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enchance on radionuclide bone scan
Original Application #: 020683
Approval Date: 27-MAR-97
Trade Name: ALESSE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETHINYL ESTRADIOL; LEVONORGESTREL
OTC/RX Status: RX
Indication(s): For the prevention of pregnancy
Original Application #: 020678
Approval Date: 26-MAR-97
Trade Name: CLINIMIX E
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): AMINO ACID WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM
OTC/RX Status: RX
Indication(s): Used as a source of calories and protein in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption is impaired, or (3) metabolic requirements for protein are substantially increased
Original Application #: 020779
Approval Date: 14-MAR-97
Trade Name: VIRACEPT
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Indication(s): Treatment of HIV infection when therapy is warranted
Original Application #: 020778
Approval Date: 14-MAR-97
Trade Name: VIRACEPT
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: POWDER
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Indication(s): Treatment of HIV infection when therapy is warranted
Original Application #: 020333
Approval Date: 14-MAR-97
Trade Name: AGRYLIN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: ROBERTS PHARMACEUTICAL CORP
Active Ingredient(s): ANAGRELIDE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of patients with essential thrombocythemia to reduce the elevated platelet count and the risk of thrombosis and ameliorate associated systems
Original Application #: 020529
Approval Date: 13-MAR-97
Trade Name: CONDYLOX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: OCLASSEN PHARMACEUTICALS INC
Active Ingredient(s): PODOFILOX
OTC/RX Status: RX
Indication(s): Treatment of anogential warts (external genital warts and perianal warts)
Original Application #: 020490
Approval Date: 13-MAR-97
Trade Name: ALPHAGAN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: ALLERGAN INC
Active Ingredient(s): BRIMONIDINE TARTRATE
OTC/RX Status: RX
Indication(s): Prevention of post-operative IOP elevations in patients undergoing argon laser trabeculoplasty (ALT)
Original Application #: 020708
Approval Date: 07-MAR-97
Trade Name: LUPRON DEPOT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Indication(s): The management of endometriosis, including pain relief and reduction of endometriotic lesions; and preoperative hematologic improvement of patients with anemia cuased by uterine leiomyomata (fibroids) when used concomitantly with iron therapy
Original Application #: 020707
Approval Date: 07-MAR-97
Trade Name: SKELID
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SANOFI WINTHROP INC
Active Ingredient(s): TILUDRONATE DISODIUM
OTC/RX Status: RX
Indication(s): Treatment of Paget's disease of bone
Original Application #: 020611
Approval Date: 03-MAR-97
Trade Name: DOVONEX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CALCIPOTRIENE HYDRATE
OTC/RX Status: RX
Indication(s): For topical treatment of chronic, moderately severe psoriasis of the scalp
Efficacy Supplemental New Drug Applications
Application #:020243Efficacy Supplement#: 006
Type: SE5 to Original New Drug Application
Approval Date: 25-MAR-97
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX
Efficacy Claim: Treatment of obsessive compulsive disorder in the pediatric population
Application #:020522 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 24-MAR-97
Trade Name: NUTROPIN AQ
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Efficacy Claim: Treatment of growth failure associated with Turner Syndrome
Application #:020273Efficacy Supplement#: 003
Type: SE2 to Original New Drug Application
Approval Date: 20-MAR-97
Trade Name: DOVONEX
Dosage Form: OINTMENT
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CALCIPOTRIENE
OTC/RX Status: RX
Efficacy Claim: Once daily dosing for plaque psoriasis
Application #:018654Efficacy Supplement#: 030
Type: SE2 to Original New Drug Application
Approval Date: 18-MAR-97
Trade Name: VERSED
Dosage Form: INJECTABLE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For sedation in pediatric patients
Application #:019640Efficacy Supplement#:018
Type: SE1 to Original New Drug Application
Approval Date: 11-MAR-97
Trade Name: HUMATROPE
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Efficacy Claim: New indication for Turner's Syndrome
Application #:019660 Efficacy Supplement#:015
Type: SE1 to Original New Drug Application
Approval Date: 06-MAR-97
Trade Name: TILADE
Dosage Form: AEROSOL
Applicant: RHONE-POULENC RORER PHARMACEUTICALS INC.
Active Ingredient(s): NEDOCROMIL SODIUM
OTC/RX Status: RX
Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age
Approvable Original New Drug Applications
Original Application #: 019781
Approvable Date: 31-MAR-97
Trade Name: PROMETRIUM
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Original Application #: 020675
Approvable Date: 24-MAR-97
Trade Name: URSO
Dosage Form: TABLET
Applicant: AXCAN PHARMA US INC
Active Ingredient(s): URSODIOL
OTC/RX Status: RX
Original Application #: 020712
Approvable Date: 20-MAR-97
Trade Name: CARBATROL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: PHARMAVENE INC
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX
Original Application #: 020623
Approvable Date: 05-MAR-97
Trade Name: ANZEMET
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DOLASETRON MESYLATE
OTC/RX Status: RX
Original Abbreviated New Drug Applications
Original Abbreviated Application # 074640
Approval Date: 31-MAR-97
Trade Name: CAPTOPRIL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX
Original Abbreviated Application # 074741
Approval Date: 28-MAR-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICALS SUB FH FAULDING AND CO LTD
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 074740
Approval Date: 28-MAR-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICALS SUB FH FAULDING AND CO LTD
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 074532
Approval Date: 28-MAR-97
Trade Name: CAPTOPRIL
Dosage Form: TABLET
Applicant: WOCKHARDT LTD
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX
Original Abbreviated Application # 074412
Approval Date: 28-MAR-97
Trade Name: CIMETIDINE HCL
Dosage Form: INJECTABLE
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074296
Approval Date: 28-MAR-97
Trade Name: CIMETIDINE HCL
Dosage Form: INJECTABLE
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 073101
Approval Date: 28-MAR-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: TABLET
Applicant: PHARMACHEMIE BV
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX
Original Abbreviated Application # 073099
Approval Date: 28-MAR-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: TABLET
Applicant: PHARMACHEMIE BV
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX
Original Abbreviated Application # 040145
Approval Date: 26-MAR-97
Trade Name: WARFARIN SODIUM
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX
Original Abbreviated Application # 074778
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074776
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: BAUSCH AND LOMB INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074747
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: PACIFIC PHARMA INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074746
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: PACIFIC PHARMA INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074668
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: E FOUGERA DIV ALTANA INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074667
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: E FOUGERA DIV ALTANA INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074639
Approval Date: 25-MAR-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 074516
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: AKORN INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074515
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: AKORN INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074466
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: ADVANCED REMEDIES INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074465
Approval Date: 25-MAR-97
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION, DROPS
Applicant: ADVANCED REMEDIES INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 074702
Approval Date: 24-MAR-97
Trade Name: METAPROTERENOL SULFATE
Dosage Form: SYRUP
Applicant: JVL CORP
Active Ingredient(s): METAPROTERENOL SULFATE
OTC/RX Status: RX
Original Abbreviated Application # 074395
Approval Date: 20-MAR-97
Trade Name: MICONAZOLE NITRATE
Dosage Form: SUPPOSITORY
Applicant: L PERRIGO CO
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: RX
Original Abbreviated Application # 074648
Approval Date: 18-MAR-97
Trade Name: LORAZEPAM
Dosage Form: SOLUTION
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX
Original Abbreviated Application # 040110
Approval Date: 12-MAR-97
Trade Name: MEPERIDINE HCL
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040188
Approval Date: 07-MAR-97
Trade Name: CARISOPRODOL
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): CARISOPRODOL
OTC/RX Status: RX
Original Abbreviated Application # 040083
Approval Date: 07-MAR-97
Trade Name: PHENTERMINE HCL
Dosage Form: CAPSULE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval
Original Abbreviated Application #: 074674
Tentative Approval Date: 28-MAR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX
Original Abbreviated Application #: 074872
Tentative Approval Date: 27-MAR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: ESI LEDERLE INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX
Original Abbreviated Application #: 074828
Tentative Approval Date: 27-MAR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX
Original Abbreviated Application #: 074758
Tentative Approval Date: 27-MAR-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX
Original Abbreviated Application #: 074658
Tentative Approval Date: 27-MAR-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL CO
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX
Original Abbreviated Application #: 074750
Tentative Approval Date: 21-MAR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL CO
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX
Original Abbreviated Application #: 074680
Tentative Approval Date: 12-MAR-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074657
Tentative Approval Date: 07-MAR-97
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074726
Tentative Approval Date: 6-MAR-97
Trade Name: KLOR-CON M20
Dosage Form: TABLET
Applicant: UPSHER SMITH LABS
Active Ingredient(s): POTASSIUM CHLORIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #:020516Labeling Supplement#:001
To Original New Drug Application
Approval Date: 31-MAR-97
Trade Name: CHILDREN'S MOTRIN
Dosage Form: SUSPENSION
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Application #:020068Labeling Supplement#:009
To Original New Drug Application
Approval Date: 31-MAR-97
Trade Name: FOSCAVIR
Dosage Form: INJECTABLE
Applicant: ASTRA USA INC
Active Ingredient(s): FOSCARNET SODIUM
OTC/RX Status: RX
Application #:019012Labeling Supplement#:003
To Original New Drug Application
Approval Date: 31-MAR-97
Trade Name: NUPRIN
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Application #:018060Labeling Supplement#:055
To Original New Drug Application
Approval Date: 31-MAR-97
Trade Name: ACEPHEN
Dosage Form: SUPPOSITORY
Applicant: G AND W LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN
OTC/RX Status: OTC
Application #:009486Labeling Supplement#:021
To Original New Drug Application
Approval Date: 31-MAR-97
Trade Name: BENADRYL
Dosage Form: INJECTABLE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): DIPHENHYDRAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #:008847Labeling Supplement#:011
To Original New Drug Application
Approval Date: 28-MAR-97
Trade Name: SUCOSTRIN
Dosage Form: INJECTABLE
Applicant: APOTHECON INC
Active Ingredient(s): SUCCINYLCHOLINE CHLORIDE
OTC/RX Status: RX
Application #:020064Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 27-MAR-97
Trade Name: MACROBID
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE; NITROFURANTOIN
OTC/RX Status: RX
Application #:017279Labeling Supplement#:007
To Original New Drug Application
Approval Date: 27-MAR-97
Trade Name: GLOFIL-125
Dosage Form: INJECTABLE
Applicant: CYPROS PHARMACEUTICAL CORP
Active Ingredient(s): IOTHALAMATE SODIUM, I-125
OTC/RX Status: RX
Application #:016620Labeling Supplement#:061
To Original New Drug Application
Approval Date: 27-MAR-97
Trade Name: MACRODANTIN
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE
OTC/RX Status: RX
Application #:009175Labeling Supplement#:023
To Original New Drug Application
Approval Date: 27-MAR-97
Trade Name: FURADANTIN
Dosage Form: SUSPENSION
Applicant: DURA PHARMACEUTICALS INC
Active Ingredient(s): NITROFURANTOIN
OTC/RX Status: RX
Application #:008693Labeling Supplement#:029
To Original New Drug Application
Approval Date: 27-MAR-97
Trade Name: FURADANTIN
Dosage Form: TABLET
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN
OTC/RX STATUS: RX
Application#:020101Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 25-MAR-97
Trade Name: PROZAC
Dosage Form: SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application#:018936Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 25-MAR-97
Trade Name: PROZAC
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application #:008578Labeling Supplement#:013
To Original New Drug Application
Approval Date: 25-MAR-97
Trade Name: DARAPRIM
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): PYRIMETHAMINE
OTC/RX Status: RX
Application#:050685Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 24-MAR-97
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX
Application#:020239Labeling Supplement #:007
To Original New Drug Application
Approval Date: 20-MAR-97
Trade Name: KYTRIL
Dosage Form: INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): GRANISETRON HYDROCHLORIDE
OTC/RX Status: RX
Application#:050726Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '200'
Dosage Form: TABLET, CHEWABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050726Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '400'
Dosage Form: TABLET, CHEWABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050725Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '200'
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050725Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '400'
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050720Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '875'
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050675Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: VANTIN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: UPJOHN TRADING CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Application#:050597Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '125'
Dosage Form: TABLET, CHEWABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050597Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '250'
Dosage Form: TABLET, CHEWABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050575Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '125'
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050575Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '250'
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050564Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '250'
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050564Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: AUGMENTIN '500'
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Application#:050519Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: NEBCIN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): TOBRAMYCIN SULFATE
OTC/RX Status: RX
Application#:050477Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: NEBCIN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): TOBRAMYCIN SULFATE
OTC/RX Status: RX
Application #:019151Labeling Supplement#:004
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: RYTHMOL
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): PROPAFENONE HYDROCHLORIDE
OTC/RX Status: RX
Application#:018452Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:018452Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:018452Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:018452Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:017598Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:017598Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:017598Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:017376Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:017376Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application#:017376Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: SEPTRA
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application #:013601Labeling Supplement#:052
To Original New Drug Application
Approval Date: 19-MAR-97
Trade Name: MUCOMYST
Dosage Form: SOLUTION
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): ACETYLCYSTEINE
OTC/RX Status: RX
Application#:050639Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 17-MAR-97
Trade Name: CLEOCIN PHOSPHATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Application#:050441Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 17-MAR-97
Trade Name: CLEOCIN PHOSPHATE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Application#:050441Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 17-MAR-97
Trade Name: CLEOCIN PHOSPHATE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Application#:050162Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 17-MAR-97
Trade Name: CLEOCIN HCL
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN HYDROCHLORIDE
OTC/RX Status: RX
Application#:050162Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 17-MAR-97
Trade Name: CLEOCIN HCL
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN HYDROCHLORIDE
OTC/RX Status: RX
Application#:050162Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-MAR-97
Trade Name: CLEOCIN HCL
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN HYDROCHLORIDE
OTC/RX Status: RX
Application #:020415Labeling Supplement#:003
To Original New Drug Application
Approval Date: 17-MAR-97
Trade Name: REMERON
Dosage Form: TABLET
Applicant: ORGANON
Active Ingredient(s):MIRTAZAPINE
OTC/RX Status: RX
Application #:020364Labeling Supplement#:007
To Original New Drug Application
Approval Date: 14-MAR-97
Trade Name: LOTREL
Dosage Form: CAPSULE
Applicant: CIBA GEIGY CORP
Active Ingredient(s): AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
OTC/RX Status: RX
Application #:020241Labeling Supplement#:004
To Original New Drug Application
Approval Date: 11-MAR-97
Trade Name: LAMICTAL
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX
Application #:020237Labeling Supplement#:006
To Original New Drug Application
Approval Date: 11-MAR-97
Trade Name: SALAGEN
Dosage Form: TABLET
Applicant: MGI PHARMA INC
Active Ingredient(s): PILOCARPINE HYDROCHLORIDE
OTC/RX Status: RX
Application #:019640Labeling Supplement#:019
To Original New Drug Application
Approval Date: 11-MAR-97
Trade Name: HUMATROPE
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Application #:013026Labeling Supplement#:009
To Original New Drug Application
Approval Date: 10-MAR-97
Trade Name: TRECATOR-SC
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETHIONAMIDE
OTC/RX Status: RX
Application #:020571Labeling Supplement#:004
To Original New Drug Application
Approval Date: 07-MAR-97
Trade Name: CAMPTOSAR
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): IRINOTECAN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 008678 Labeling Supplement #:021 To Original New Drug Application
Approval Date: 06-MAR-97
Trade Name: ISONIAZID
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ISONIAZID
OTC/RX Status: RX
Application #:018746 Labeling Supplement#: 009 To Original New Drug Application
Approval Date: 06-MAR-97
Trade Name: VASOCON-A
Dosage Form: SOLUTION/DROPS
Applicant: CIBAVISION OPHTHALMICS
Active Ingredient(s): ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE
OTC/RX Status: RX
Application #:017007 Labeling Supplement#: 036 To Original New Drug Application
Approval Date: 05-MAR-97
Trade Name: HEPARIN SODIUM (LOCK FLUSH; FLUSH KITS)
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX
Application #:018107 Labeling Supplement#: 004 To Original New Drug Application
Approval Date: 04-MAR-97
Trade Name: MDP-BRACCO
Dosage Form: INJECTABLE
Applicant: BRACCO DIAGNOSTICS
Active Ingredient(s): TECHNETIUM Tc 99m MEDRONATE
OTC/RX Status: RX
Application #:018521Labeling Supplement#: 025 To Original New Drug Application
Approval Date: 03-MAR-97
Trade Name: VANCENASE
Dosage Form: AEROSOL, METERED
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
OTC/RX Status: RX
Approvable Original New Drug Applications
An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by FDA, and has been notified in writing that the application has been approved. Further information on approvable NDAs is not subject to Freedom of Information (FOI) release until applications are approved.
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
A tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or 505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent Term Restoration Act. Such drug products that are the subjects of tentative approvals may not be legally marketed until the market exclusivity and/or patent term of the listed reference drug product has expired. Final approval is also contingent upon conditions and information available to FDA remaining acceptable. When the application receives final approval, the product may be legally marketed. The effective approval date will be listed in this publication and in the " Approved Drug Products with Therapeutic Equivalence Evaluations" list published by FDA. Additional information on these applications will become available to the public when the applications receive final approval. Notes
FDA classifies investigational new drug applications (INDs) and new drug applications (NDAs) to assign review priority on the basis of the drug's chemical type and potential benefit:
Chemical Type (CHE)
1. New molecular entity, or NME: An active ingredient that has never been marketed in this country.
2. New derivative: A chemical derived from an active ingredient already marketed (a "parent" drug).
3. New formulation: A new dosageform or new formulation of an active ingredient already on the market.
4. New combination: A drug that contains two or more compounds, the combination of which has not been marketed together in a product.
5. Already marketed drug product but a new manufacturer: A product that duplicates another firm's already marketed drug product: same active ingredient, formulation, or combination.
6. Already marketed drug product, but a new use: A new use for a drug product already marketed by a different firm.
Effectiveness Supplement Code Definitions
SE1 A new indication or a significant modification of an existing indication, including removal of a major limitation to use, such as second line status.
SE2 A new dosage regimen, including an increase or decrease in daily dosage, or a change in frequency of administration.
SE3 A new route of administration.
SE4 A comparative efficacy claim naming another drug, including a comparative pharmacokinetic claim.
SE5 A change in sections other than the INDICATIONS AND USAGE section that would significantly alter the patient population to be treated, such as addition of pediatric use and/or dosing information or geriatric use and/or dosing information.
An Rx-to-OTC switch.
Treatment Potential (TP)
P Priority review drug: A drug that appears to represent an advance over available therapy
Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug.
Other Designations (may apply simultaneously)
AA AIDS drug: A drug indicated for treating AIDS or other HIV related disease.
E Subpart E drug: A drug developed or evaluated under special procedures for drugs to treat lifethreatening or severely debilitating illnesses. (The name refers to Title 21 of the Code of Federal Regulations, Part 312, Subpart E, which governs this classification. Also see, "The Evolution of U.S. Drug Law," page 26 of the booklet,  From Test Tube to Patient: NEW DRUG DEVELOPMENT IN THE UNITED STATES.)
V Designated orphan drug: A drug for which the sponsor received orphan designation under the Orphan Drug Act. Such a sponsor is eligible for tax credits and exclusive marketing rights for the drug.
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Last update: June 24, 2005
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