| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
78-008 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
AUROBINDO PHARMA LIMITED |
10/2/2006 |
| 2 |
77-534 |
CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
INVAGEN PHARMACEUTICALS, INC. |
10/3/2006 |
| 3 |
77-743 |
RIBAVIRIN TABLETS, 200 MG |
SANDOZ INC. |
10/3/2006 |
| 4 |
77-894 |
GABAPENTIN TABLETS, 100 MG, 300 MG, AND 400 MG |
APOTEX INC. |
10/10/2006 |
| 5 |
77-824 |
RANITIDINE TABLETS USP, 150 MG AND 300 MG |
INTERPHARM INC. |
10/13/2006 |
| 6 |
77-960 |
VALPROIC ACID SYRUP (VALPROIC ACID ORAL SOLUTION, USP), 250 MG/5 ML |
VINTAGE PHARMACEUTICALS, LLC |
10/13/2006 |
| 7 |
65-307 |
CEFADROXIL FOR ORAL SUSPENSION USP, 250 MG/5 ML AND 500 MG/5 ML |
ORCHID HEALTHCARE |
10/16/2006 |
| 8 |
77-625 |
ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG |
ZYDUS PHARMACEUTICALS USA,INC. |
10/16/2006 |
| 9 |
76-341 |
PRAVASTATIN SODIUM TALBETS, 10 MG, 20 MG, AND 40 MG |
APOTEX INC. |
10/23/2006 |
| 10 |
76-397 |
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG |
LEK PHARMACEUTICALS d.d. |
10/23/2006 |
| 11 |
76-714 |
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG |
DR. REDDY'S LABORATORIES LIMITED |
10/23/2006 |
| 12 |
76-939 |
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG |
COBALT PHARMACEUTICALS, INC. |
10/23/2006 |
| 13 |
77-013 |
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG |
GENPHARM INC. |
10/23/2006 |
| 14 |
77-904 |
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG |
WATSON LABORATORIES, INC. |
10/23/2006 |
| 15 |
77-510 |
COLESTIPOL HYDROCHLORIDE TABLETS, 1 G |
IMPAX LABORATORIES, INC. |
10/24/2006 |
| 16 |
40-603 |
PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES USP, 12.5 MG AND 25 MG |
TARO PHARMACEUTICALS U.S.A., INC. |
10/26/2006 |
| 17 |
40-620 |
METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION USP, 40 MG/ML AND 80 MG/ML |
SICOR PHARMACEUTICALS, INC. |
10/27/2006 |
| 18 |
78-325 |
NICOTINE POLACRILEX GEM USP, (MINT FLAVOR) OTC 2 MG (BASE)/PIECE |
PERRIGO R&D COMPANY |
10/30/2006 |
| 19 |
78-326 |
NICOTINE POLACRILEX GUM USP, (MINT-FLAVOR) OTC 4 MG (BASE)/PIECE |
PERRIGO R&D COMPANY |
10/30/2006 |
| 20 |
77-190 |
MILRINONE LACTATE INJECTION, 1 MG (BASE)/ML; 5 ML SYRINGE |
GLAND PHARMA LIMITED |
10/31/2006 |
| 21 |
77-264 |
METRONIDAZOLE VAGINAL GEL, 0.75% |
QLT USA, INC. |
10/31/2006 |