| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-345 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
PUREPAC PHARMACEUTICAL COMPANY |
12/6/2005 |
| 2 |
76-748 |
ROSIGLITAZONE MALEATE TABLETS, 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE) |
DR. REDDY'S LABORATORIES LIMITED |
12/7/2005 |
| 3 |
77-129 |
RIVASTIGMINE TARTRATE CAPSULES, 1.5 MG (BASE), 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE) |
WATSON LABORATORIES, INC. |
12/7/2005 |
| 4 |
77-376 |
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, 45 MG |
AUROBINDO PHARMA LIMITED |
12/8/2005 |
| 5 |
76-798 |
PIOGLITAZONE HYDROCHLORIDE TABLETS, 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE) |
WATSON LABORATORIES, INC. |
12/13/2005 |
| 6 |
77-136 |
TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE) |
GENPHARM INC. |
12/13/2005 |
| 7 |
76-596 |
MODAFINIL TABLETS, 100 MG AND 200 MG |
TEVA PHARMACEUTICALS USA |
12/16/2005 |
| 8 |
77-299 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
PLIVA HRVATSKA D.O.O. |
12/21/2005 |
| 9 |
77-363 |
RIVASTIGMINE TARTRATE ORAL SOLUTION, 2 MG (BASE)/ML |
RANBAXY INC. |
12/21/2005 |
| 10 |
77-774 |
STAVUDINE FOR ORAL SOLUTION USP, 1 MG/ML |
AUROBINDO PHARMA LIMITED |
12/21/2005 |
| 11 |
76-442 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
DR. REDDY'S LABORATORIES LIMITED |
12/27/2005 |
| 12 |
77-221 |
LAMIVUDINE TABLETS, 150 MG AND 300 MG |
WATSON LABORATORIES, INC. |
12/27/2005 |
| 13 |
77-378 |
CARVEDILOL TABLETS, 3.125 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
12/27/2005 |
| 14 |
77-702 |
NEVIRAPINE ORAL SUSPENSION, 50 MG/5 ML |
AUROBINDO PHARMA LIMITED |
12/29/2005 |
| 15 |
77-335 |
FINASTERIDE TABLETS USP, 1 MG |
WATSON LABORATORIES, INC. |
12/29/2005 |
| 16 |
76-532 |
SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG |
TEVA PHARMACEUTICALS USA |
12/30/2005 |
