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Tentative Approvals - November 2006
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-472 |
CETIRIZINE HYDROCHLORIDE SYRUP, 5 MG/5 ML |
RANBAXY INC. |
11/1/2006 |
| 2 |
76-601 |
CETIRIZINE HYDROCHLORIDE SYRUP, 5 MG/5 ML |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
11/3/2006 |
| 3 |
78-119 |
ABACAVIR SULFATE TABLETS, 300 MG (BASE) |
CIPLA LTD. |
11/6/2006 |
| 4 |
77-837 |
SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, 80 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
11/6/2006 |
| 5 |
77-243 |
OLANZAPINE ORALLY DISINTEGRATING TABLETS, 5 MG, 10 MG, 15 MG, AND 20 MG |
BARR LABORATORIES, INC. |
11/8/2006 |
| 6 |
77-887 |
CARVEDILOL TABLETS, 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG |
HIKMA PHARMACEUTICALS |
11/14/2006 |
| 7 |
77-491 |
PRAVASTATIN SODIUM TABLETS, 80 MG |
LEK PHARMACEUTICALS d.d. |
11/14/2006 |
| 8 |
77-256 |
TRANDOLAPRIL TABLET, 1 MG, 2 MG, AND 4 MG |
COREPHARMA, LLC |
11/20/2006 |
| 9 |
77-766 |
SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG |
SANDOZ INC. |
11/21/2006 |
| 10 |
77-730 |
PRAVASTATIN SODIUM TABLETS, 80 MG |
PLIVA HRVATSKA, d.o.o. |
11/21/2006 |
| 11 |
77-406 |
ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, 16 MG AND 24 MG |
KALI LABORATORIES, INC. |
11/27/2006 |
| 12 |
77251 |
FINASTERIDE TABLETS USP, 5 MG |
GEDEON RICHTER LTD. |
11/27/2006 |
| 13 |
77-600 |
DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1% |
APOTEX INC. |
11/28/2006 |
| 14 |
77-718 |
POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 GRAMS/SCOOPFUL |
PENTECH PHARMACEUTICALS, INC. |
11/28/2006 |
| 15 |
77-343 |
ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALS |
APOTEX INC. |
11/28/2006 |
| 16 |
77-544 |
ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS |
PLIVA HRVATSKA d.o.o. |
11/28/2006 |
| 17 |
76-840 |
SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
TEVA PHARMACEUTICALS USA |
11/28/2006 |
| 18 |
77-845 |
DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1% |
AKORN INC. |
11/29/2006 |
| 19 |
78-053 |
SERTRALINE HYDROCHLORIDE ORAL CONCENTRATE, 20 MG (BASE)/ML |
RANBAXY INC. |
11/30/2006 |
| 20 |
77-368 |
ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS |
APOTEX INC. |
11/30/2006 |
| 21 |
77-752 |
SIMVASTATIN TABLETS USP, 10 MG, 20 MG, 40 MG, AND 80 MG |
DR. REDDY'S LABORATORIES LIMITED |
11/30/2006 |
| 22 |
77-437 |
MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG |
TEVA PHARMACEUTICALS USA |
11/30/2006 |
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Date created: December 7, 2006 |
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