|
Drug Approvals for July 2001
Definitions and Notes
Original New Drug Applications
Original Application #: 021064
Approval Date: 31-JUL-01
Trade Name: DEFINITY
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTION
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): PERFLUTREN LIPID MICROSPHERE
OTC/RX Status: RX
Indication(s): For the treatment patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border
Original Application #: 021283
Approval Date: 18-JUL-01
Trade Name: DIOVAN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): VALSARTAN
OTC/RX Status: RX
Indication(s):For the treatment of hypertension
Original Application #: 021146
Approval Date: 09-JUL-01
Trade Name: ATROPINE SULFATE
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): ATROPINE SULFATE
OTC/RX Status: RX
Indication(s): For the use when excessive (or sometimes normal) muscarinic effects are judged to be life threatening or are producing symptoms severe enough to call for temporary, reversible muscarinic blockade
Original Application #: 021276
Approval Date: 01-JUL-01
Trade Name: ESTROSTEP
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX
Indication(s): For the treatment of moderate acne vulgaris in females, age 15 years or older, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications
Efficacy Supplemental New Drug Applications
Application #: 020280 Efficacy Supplement#: 031
Type: SE1 to Original New Drug Application
Approval Date: 25-JUL-01
Trade Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form: POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX
Efficacy Claim:
Application #: 020280 Efficacy Supplement #: 031
Type: SE1 to Original New Drug Application
Approval Date: 25-JUL-01
Trade Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX
Efficacy Claim: For long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up by two years of age
Application #: 018731 Efficacy Supplement #: 043
Type: SE5 to Original New Drug Application
Approval Date: 19-JUL-01
Trade Name: BUSPAR
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the management of anxiety disorders or the short-term relief of the symptoms of anxiety
Application #: 020550 Efficacy Supplement #: 012
Type: SE2 to Original New Drug Application
Approval Date: 25-JUN-01
Trade Name: VALTREX
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s):VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of recurrent episodes of genital herpes
Approvable Original New Drug Applications
Original Application #: 021324
Approvable Date: 24-JUL-01
Trade Name: ENTOCORT
Dosage Form: CAPSULE
Applicant: ASTRAZENECA LP
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX
Original Abbreviated Application # 075442
Approval Date: 31-JUL-01
Trade Name: FLECAINIDE ACETATE
Dosage Form: TABLET
Applicant: ALPHAPHARM PARTY LTD
Active Ingredient(s): FLECAINIDE ACETATE
OTC/RX Status: RX
Original Abbreviated Application # 075626
Approval Date: 24-JUL-01
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: INJECTABLE
Applicant: APOTEX CORP
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Original Abbreviated Application # 075611
Approval Date: 23-JUL-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: TORPHARM
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 040394
Approval Date: 23-JUL-01
Trade Name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form: TABLET
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN; BUTALBITAL; CAFFEINE
OTC/RX Status: RX
Original Abbreviated Application # 040390
Approval Date: 23-JUL-01
Trade Name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage Form: TABLET
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN; BUTALBITAL; CAFFEINE
OTC/RX Status: RX
Original Abbreviated Application # 075838
Approval Date: 11-JUL-01
Trade Name: PROPOXYPHENE NAPSYLATE and ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ABLE LABORATORIES, INC
Active Ingredient(s): PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN
OTC/RX Status: RX
Original Abbreviated Application # 040407
Approval Date: 11-JUL-01
Trade Name: PROCHLORPERAZINE SUPPOSITORIES
Dosage Form: SUPPOSITORY
Applicant: ABLE LABORATORIES, INC
Active Ingredient(s):PROCHLORPERAZINE
OTC/RX Status: RX
Original Abbreviated Application # 075712
Approval Date: 05-JUL-01
Trade Name: CARBAMAZEPINE
Dosage Form: TABLET, CHEWABLE
Applicant: CARACO PHARMACEUTICAL LABORATORIES, LTD
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: OTC
Original Abbreviated Application # 075416
Approval Date: 05-JUL-01
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET, EXTENDED-RELEASE
Applicant: ANDRX PHARMACEUTICALS, INC
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: OTC
Original Abbreviated Application # 075702
Approval Date: 03-JUL-01
Trade Name: CROMOLYN SODIUM
Dosage Form: SPRAY, METERED
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: OTC
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075882
Tentative Approval Date: 31-JUL-01
Trade Name: FLECAINIDE ACETATE
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): FLECAINIDE ACETATE
OTC/RX Status: RX
Original Abbreviated Application #: 075465
Tentative Approval Date: 26-JUN-01
Trade Name: FLUOEXTINE
Dosage Form: CAPSULE
Applicant: DR. REDDY'S LABORATORIES LIMITED
Active Ingredient(s): FLUOEXTINE
OTC/RX Status: RX
Original Abbreviated Application #: 075576
Tentative Approval Date: 25-JUN-01
Trade Name:OMEPRAZOLE
Dosage Form: CAPSULE
Applicant: DR. REDDY'S LABORATORIES LIMITED
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX
Original Abbreviated Application #: 075451
Tentative Approval Date: 18-JUL-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX
Original Abbreviated Application #: 075300
Tentative Approval Date: 18-JUL-01
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX
Original Abbreviated Application #: 075794
Tentative Approval Date: 12-JUL-01
Trade Name: ACETAMINOPHEN, ASPIRIN, AND CAFFEINE
Dosage Form: TABLET
Applicant: L. PERRIGO COMPANY
Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 019906 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 31-JUL-01
Trade Name: ANAFRANIL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018013 Labeling Supplement#: 053
To Original New Drug Application
Approval Date: 31-JUL-01
Trade Name: PAMELOR
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018012 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 31-JUL-01
Trade Name: PAMELOR
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 016758 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 31-JUL-01
Trade Name: NAVANE
Dosage Form: CONCENTRATE
Applicant: ROERIG DIV PFIZER INC
Active Ingredient(s): THIOTHIXENE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 016584 Labeling Supplement #: 055
To Original New Drug Application
Approval Date: 31-JUL-01
Trade Name: NAVANE
Dosage Form: CAPSULE
Applicant: ROERIG DIV PFIZER INC
Active Ingredient(s): THIOTHIXENE
OTC/RX Status: RX
Application #:019404 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 30-JUL-01
Trade Name: OCUFEN
Dosage Form: SOLUTION
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): FLURBIPROFEN SODIUM
OTC/RX Status: RX
Application #: 050709 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 25-JUL-01
Trade Name: PROGRAF
Dosage Form: INJECTABLE
Applicant: FUJISAWA HEALTHCARE INC
Active Ingredient(s): TACROLIMUS
OTC/RX Status: RX
Application #: 050708 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 25-JUL-01
Trade Name: PROGRAF
Dosage Form: CAPSULE
Applicant: FUJISAWA HEALTHCARE INC
Active Ingredient(s): TACROLIMUS
OTC/RX Status: RX
Application #: 050708 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 25-JUL-01
Trade Name: PROGRAF
Dosage Form: CAPSULE
Applicant: FUJISAWA HEALTHCARE INC
Active Ingredient(s): TACROLIMUS
OTC/RX Status: RX
Application #: 021246 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 24-JUL-01
Trade Name: TAMIFLU
Dosage Form: SUSPENSION
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX
Application #: 021246 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 24-JUL-01
Trade Name: TAMIFLU
Dosage Form:SUSPENSION
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX
Application #: 021087 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 24-JUL-01
Trade Name: TAMIFLU
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX
Application #: 021087 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 24-JUL-01
Trade Name: TAMIFLU
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX
Application #: 018554 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: EULEXIN
Dosage Form: CAPSULE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): FLUTAMIDE
OTC/RX Status: RX
Application #: 012418 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON LACTATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN LACTATE
OTC/RX Status: RX
Application #: 012418 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON LACTATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN LACTATE
OTC/RX Status: RX
Application #: 012418 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON LACTATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN LACTATE
OTC/RX Status: RX
Application #: 012418 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON LACTATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN LACTATE
OTC/RX Status: RX
Application #: 012003 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 012003 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 012003 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 012003 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 23-JUL-01
Trade Name: AKINETON
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): BIPERIDEN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 021066 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 20-JUL-01
Trade Name: ZADITOR
Dosage Form: SOLUTION, DROPS
Applicant: CIBA VISION CORP DIV NOVARTIS CO
Active Ingredient(s): KETOTIFEN FUMARATE
OTC/RX Status: RX
Application #: 020987 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 20-JUL-01
Trade Name: PROTONIX
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX
Application #: 020553 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 18-JUL-01
Trade Name: OXYCONTIN
Dosage Form: TABLET
Applicant: PURDUE PHARMA LP
Active Ingredient(s): OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019034 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 18-JUL-01
Trade Name: DILAUDID-HP
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): HYDROMORPHONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019977 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 13-JUL-01
Trade Name: ORAMORPH SR
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Application #: 019977 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 13-JUL-01
Trade Name: ORAMORPH SR
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Application #: 011559 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 13-JUL-01
Trade Name: BREVITAL SODIUM
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): METHOHEXITAL SODIUM
OTC/RX Status: RX
Application #: 050643 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 12-JUL-01
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX
Application #: 050558 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 12-JUL-01
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX
Application #: 020622 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 12-JUL-01
Trade Name: COPAXONE
Dosage Form: INJECTABLE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): GLATIRAMER ACETATE
OTC/RX Status: RX
Application #: 019832 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 12-JUL-01
Trade Name: SULFAMYLON
Dosage Form: SOLUTION
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): MAFENIDE ACETATE
OTC/RX Status: RX
Application #: 020872 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 11-JUL-01
Trade Name: ALLEGRA
Dosage Form: TABLET
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020625 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 11-JUL-01
Trade Name: ALLEGRA
Dosage Form: CAPSULE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020377 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 11-JUL-01
Trade Name: CORDARONE
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 20377 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 11-JUL-01
Trade Name: CORDARONE
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019515 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 11-JUL-01
Trade Name: IONOSOL B AND DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): SODIUM LACTATE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; DEXTROSE
OTC/RX Status: RX
Application #: 020714 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 09-JUL-01
Trade Name: NICOTROL
Dosage Form: INHALATION
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Application #: 020385 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 09-JUL-01
Trade Name: NICOTROL
Dosage Form: SPRAY, METERED
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Application #: 020988 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 03-JUL-01
Trade Name: PROTONIX IV
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX
Application #: 021073 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 02-JUL-01
Trade Name: ACTOS
Dosage Form: TABLET
Applicant: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Active Ingredient(s): PIOGLITAZONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 021008 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 02-JUL-01
Trade Name: SANDOSTATIN LAR
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): OCTREOTIDE ACETATE
OTC/RX Status: RX
Application #: 019667 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 02-JUL-01
Trade Name: SANDOSTATIN
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): OCTREOTIDE ACETATE
OTC/RX Status: RX
Application #: 020130 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 02-JUL-01
Trade Name: ESTROSTEP 21
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX
 Back
to Top 
Back to Drug Approvals List
Date created: September 05, 2001; last update: June 20, 2005 |
