| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-450 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
PUREPAC PHARMACEUTICAL COMPANY |
10/1/2004 |
| 2 |
76-523 |
MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG |
ROXANE LABORATORIES, INC. |
10/1/2004 |
| 3 |
76-277 |
RIBAVIRIN CAPSULES 200 MG |
TEVA PHARMACEUTICALS USA |
10/4/2004 |
| 4 |
76-895 |
PREDNISOLONE SODIUM PHOSPHATE ORAL
SOLUTION 15 MG (BASE)/5 ML |
MORTON GROVE PHARMACEUTICALS, INC. |
10/4/2004 |
| 5 |
75-565 |
LORATADINE ORAL SOLUTION, USP (OTC) 5
MG/5 ML |
APOTEX INC. |
10/5/2004 |
| 6 |
76-674 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG |
APOTEX INC. |
10/5/2004 |
| 7 |
76-271 |
KETOROLAC TROMETHAMINE INJECTION, USP 15
MG/ML; 30 MG/ML, AND 60 MG/2 ML SINGLE-DOSE VIALS |
SABEX 2002 INC. |
10/6/2004 |
| 8 |
76-912 |
CIPROFLOXACIN TABLETS, USP 250 MG, 500
MG, AND 750 MG |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
10/6/2004 |
| 9 |
75-435 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND
400 MG |
TEVA PHARMACEUTICALS USA, INC. |
10/8/2004 |
| 10 |
76-188 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG,
AND 40 MG |
SANDOZ INC. |
10/8/2004 |
| 11 |
76-256 |
FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED
IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE DOSE VIALS |
BEDFORD LABORATORIES |
10/12/2004 |
| 12 |
76-582 |
FENOLDOPAM MESYLATE INJECTION, USP 10 MG
(BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 20 MG
(BASE)/2 ML SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
10/12/2004 |
| 13 |
76-589 |
FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED
IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
10/12/2004 |
| 14 |
76-753 |
BETAMETHASONE DIPROPIONATE OINTMENT, USP
(AUGMENTED) 0.05% (BASE) |
TARO PHARMACEUTICALS U.S.A., INC. |
10/12/2004 |
| 15 |
76-755 |
FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED
IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE-DOSE VIALS |
APOTEX CORP. |
10/12/2004 |
| 16 |
76-787 |
FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED
IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE DOSE VIALS |
BAXTER HEALTHCARE CORPORATION |
10/12/2004 |
| 17 |
76-955 |
FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED
IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
10/12/2004 |
| 18 |
76-099 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150
MG, AND 450 MG SINGLE-DOSE VIALS |
BEDFORD LABORATORIES |
10/14/2004 |
| 19 |
76-162 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150
MG, AND 450 MG SINGLE-DOSE VIALS |
PHARMACHEMIE B.V. |
10/14/2004 |
| 20 |
76-235 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150
MG, AND 450 MG SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
10/14/2004 |
| 21 |
76-517 |
CARBOPLATIN INJECTION 10 MG/ML; PACKAGED
IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML SINGLE-DOSE
VIALS |
MAYNE PHARMA (USA), INC. |
10/14/2004 |
| 22 |
76-863 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 750 MG |
BARR LABORATORIES, INC. |
10/14/2004 |
| 23 |
77-269 |
CARBOPLATIN INJECTION 10 MG/ML; PACKAGED
IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML
MULTIPLE-DOSE VIALS. |
PHARMACHEMIE B.V. |
10/14/2004 |
| 24 |
76-276 |
LEVOFLOXACIN TABLETS 250 MG AND 500 MG |
MYLAN PHARMACEUTICALS, INC. |
10/15/2004 |
| 25 |
76-620 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG,
AND 40 MG |
ANDRX PHARMACEUTICALS, LLC |
10/15/2004 |
| 26 |
77-244 |
CARBOPLATIN INJECTION 10 MG/ML; PACKAGED
IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML SINGLE-DOSE
VIALS |
BEDFORD LABORATORIES |
10/15/2004 |
| 27 |
65-143 |
CEFAZOLIN FOR INJECTION, USP 10
GRAM/VIAL; (PHARMACY BULK PACKAGE) |
HIKMA FARMACEUTICA (PORTUGAL), LDA |
10/18/2004 |
| 28 |
65-190 |
CEFUROXIME AXETIL TABLETS, USP 250 MG
(BASE) AND 500 MG (BASE) |
TEVA PHARMACEUTICALS, USA |
10/18/2004 |
| 29 |
75-694 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
PUREPAC PHARMACEUTICAL CO. |
10/21/2004 |
| 30 |
77-247 |
CARBOPLATIN INJECTION 10 MG/ML; PACKAGED
IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML
MULTIPLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
10/21/2004 |
| 31 |
76-921 |
MIRTAZAPINE TABLETS 7.5 MG, 15 MG, 30 MG,
AND 45 MG |
AUROBINDO PHARMA LIMITED |
10/22/2004 |
| 32 |
76-316 |
SODIUM CHLORIDE INJECTION, USP 0.9%;
PACKAGED IN 500 ML SINGLE-DOSE FLEXIBLE PLASTIC CONTAINERS
|
HAEMONETICS CORPORATION |
10/27/2004 |
| 33 |
76-473 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150
MG, AND 450 MG SINGLE-DOSE VIALS |
MAYNE PHARMA (USA) INC. |
10/27/2004 |
| 34 |
76-486 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MG |
APOTEX INC. |
10/27/2004 |
| 35 |
76-552 |
MEDROXYPROGESTERONE ACETATE INJECTABLE
SUSPENSION, USP 150 MG/ML; PACKAGED IN 150 MG/1 ML
PREFILLED SYRINGES |
SICOR PHARMACEUTICALS, INC. |
10/27/2004 |
| 36 |
40-551 |
BETHANECHOL CHLORIDE TABLETS, USP 50 MG |
AMIDE PHARMACEUTICAL, INC. |
10/28/2004 |
| 37 |
40-552 |
BETHANECHOL CHLORIDE TABLETS, USP 5 MG |
AMIDE PHARMACEUTICAL, INC. |
10/28/2004 |
| 38 |
40-553 |
BETHANECHOL CHLORIDE TABLETS, USP 10 MG |
AMIDE PHARMACEUTICAL, INC. |
10/28/2004 |
| 39 |
40-554 |
BETHANECHOL CHLORIDE TABLETS, USP 25 MG |
AMIDE PHARMACEUTICAL, INC. |
10/28/2004 |
| 40 |
76-832 |
LITHIUM CARBONATE EXTENDED-RELEASE
TABLETS, USP 300 MG |
ROXANE LABORATORIES, INC. |
10/28/2004 |
| 41 |
77-031 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
AUROBINDO PHARMA LIMITED |
10/28/2004 |
| 42 |
77-033 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
PUREPAC PHARMACEUTICAL CO. |
10/28/2004 |
| 43 |
77-035 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
EON LABS, INC. |
10/28/2004 |
| 44 |
77-036 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
COREPHARMA LLC |
10/28/2004 |
| 45 |
77-038 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
DR. REDDY'S LABORATORIES LIMITED |
10/28/2004 |
