| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-296 |
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG (VALPROIC ACID EQUIVALENT) |
WOCKHARDT LIMITED |
6/5/2006 |
| 2 |
77-431 |
EXEMESTANE TABLETS, 25 MG |
ROXANE LABORATORIES, INC. |
6/7/2006 |
| 3 |
77-365 |
ONDANSETRON INJECTION USP, 2 MG/ML; 40 ML MULTIPLE-DOSE VIALS |
BAXTER HEALTHCARE CORPORATION |
6/9/2006 |
| 4 |
77-541 |
ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML SINGLE-DOSE VIALS |
BAXTER HEALTHCARE CORPORATION |
6/9/2006 |
| 5 |
77-254 |
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS USP, 125 MG, 250 MG, AND 500 MG (VALPROIC ACID EQUIVALENT) |
GENPHARM INC. |
6/9/2006 |
| 6 |
77-050 |
ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE) AND 8 MG (BASE) |
SUN PHARMACEUTICAL INDUSTRIES, LTD. |
6/9/2006 |
| 7 |
77-130 |
RIVASTIGMINE TARTRATE CAPSULES, 3 MG (BASE), 4.5 MG (BASE), AND 6 MG (BASE) |
DR. REDDY'S LABORATORIES LIMITED |
6/13/2006 |
| 8 |
77-157 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, 50 MG/12.5 MG AND 100 MG/25 MG |
TEVA PHARMACEUTICALS USA |
6/13/2006 |
| 9 |
77-751 |
PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 40 MG, AND 80 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
6/13/2006 |
| 10 |
77-473 |
ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML MULTIPLE-DOSE VIALS |
HOSPIRA INC. |
6/15/2006 |
| 11 |
77-548 |
ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML SINGLE-DOSE VIALS |
HOSPIRA, INC. |
6/15/2006 |
| 12 |
76-630 |
LAMOTRIGINE TABLETS, (CHEWABLE) 5 MG AND 25 MG |
GENPHARM INC. |
6/19/2006 |
| 13 |
77-428 |
LAMOTRIGINE TABLETS, 25 MG, 100 MG, 150 MG, AND 200 MG |
GENPHARM INC. |
6/21/2006 |
| 14 |
77-392 |
LAMOTRIGINE TABLETS, 25 MG, 100 MG, 150 MG, AND 200 MG |
ROXANE LABORATORIES, INC. |
6/21/2006 |
| 15 |
77-058 |
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG (BASE) AND 40 MG (BASE) |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
6/22/2006 |
| 16 |
77-980 |
LAMIVUDINE ORAL SOLUTION, 10 MG/ML |
CIPLA LIMITED |
6/22/2006 |
| 17 |
77-516 |
AMLODIPINE BESYLATE TABLETS, 2.5 MG (BASE), 5 MG (BASE) AND 10 MG (BASE) |
KALI LABORATORIES, INC. |
6/23/2006 |
| 18 |
77-950 |
ABACAVIR SULFATE ORAL SOLUTION, 20 MG/ML |
AUROBINDO PHARMA LIMITED INC. |
6/27/2006 |
| 19 |
77-672 |
STAVUDINE CAPSULES USP, 15 MG AND 20 MG |
AUROBINDO PHARMA LIMITED |
6/27/2006 |
