| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
40-633 |
BETHANECHOL CHLORIDE TABLETS USP, 5 MG |
UPSHER-SMITH LABORATORIES, INC. |
6/1/2005 |
| 2 |
40-634 |
BETHANECHOL CHLORIDE TABLETS USP, 10 MG |
UPSHER-SMITH LABORATORIES, INC. |
6/1/2005 |
| 3 |
40-635 |
BETHANECHOL CHLORIDE TABLETS USP, 25 MG |
UPSHER-SMITH LABORATORIES, INC. |
6/1/2005 |
| 4 |
40-636 |
BETHANECHOL CHLORIDE TABLETS USP, 50 MG |
UPSHER-SMITH LABORATORIES, INC. |
6/1/2005 |
| 5 |
76-827 |
VINORELBINE TARTRATE INJECTION, 10 MG
(BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 50 MG
(BASE)/5 ML SINGLE-USE VIALS |
MAYNE PHARMA (USA), INC. |
6/2/2005 |
| 6 |
40-611 |
PREDNISONE TABLETS USP, 1 MG |
TRIGEN LABORATORIES, INC. |
6/6/2005 |
| 7 |
40-576 |
CARISOPRODOL TABLETS USP, 350 MG |
NEIL LABORATORIES, INC. |
6/7/2005 |
| 8 |
77-026 |
ACYCLOVIR ORAL SUSPENSION USP, 200 MG/5
ML |
HI-TECH PHARMACAL CO., INC. |
6/7/2005 |
| 9 |
76-643 |
CARBIDOPA AND LEVODOPA TABLETS FOR ORAL
SUSPENSION 10 MG/100 MG, 25 MG/100 MG, AND 25 MG/250 MG |
RANBAXY LABORATORIES LIMITED |
6/10/2005 |
| 10 |
40-514 |
FOLIC ACID TABLETS USP, 1 MG |
TRIGEN LABORATORIES, INC. |
6/14/2005 |
| 11 |
77-096 |
CARBOPLATIN INJECTION 10 MG/ML; PACKAGED
IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML
MULTIPLE-DOSE VIALS |
SPECTRUM PHARMACEUTICALS, INC. |
6/14/2005 |
| 12 |
77-109 |
HALOBETASOL PROPIONATE OINTMENT 0.05% |
ALPHARMA USPD INC. |
6/14/2005 |
| 13 |
77-145 |
FLUTICASONE PROPIONATE OINTMENT 0.005% |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
6/14/2005 |
| 14 |
76-426 |
CIPROFLOXACIN TABLETS USP, 100 MG, 250
MG, 500 MG, AND 750 MG |
PLIVA, INC. |
6/15/2005 |
| 15 |
76-516 |
CLOTRIMAZOLE & BETAMETHASONE DIPROPIONATE
LOTION USP, 1%/0.05%(BASE) |
ALTANA INC. |
6/16/2005 |
| 16 |
76-752 |
LEVOTHYROXINE SODIUM TABLETS USP, 0.025
MG, 0.05 MG, 0.075 MG, 0.088 MG, 0.1 MG, 0.112 MG, 0.125
MG, 0.15 MG, 0.175 MG, 0.2 MG, AND 0.3 MG |
GENPHARM INC. |
6/16/2005 |
| 17 |
76-469 |
CROMOLYN SODIUM INHALATION SOLUTION USP,
10 MG/ML; PACKAGED IN 20 MG/2 ML SINGLE- DOSE AMPULES |
BREATH LIMITED |
6/17/2005 |
| 18 |
77-349 |
IBUPROFEN TABLETS USP, (OTC), 200 MG
ORANGE-COATED, ROUND & CAPSULE-SHAPED |
PERRIGO R&D COMPANY |
6/21/2005 |
| 19 |
76-463 |
HALOPERIDOL DECANOATE INJECTION 50 MG
(BASE)/ML AND 100 MG (BASE)/ML |
SABEX 2002 INC. |
6/24/2005 |
| 20 |
65-148 |
NYSTATIN ORAL SUSPENSION USP, 100,000
UNITS/ML |
VINTAGE PHARMACEUTICALS, LLC |
6/28/2005 |
| 21 |
65-248 |
CEPHALEXIN CAPSULES USP, 250 MG AND 500
MG |
ORCHID HEALTHCARE |
6/28/2005 |
| 22 |
76-716 |
GLYBURIDE AND METFORMIN HYDROCHLORIDE
TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG |
PUREPAC PHARMACEUTICAL CO. |
6/28/2005 |
| 23 |
76-901 |
MIRTAZAPINE ORALLY DISINTEGRATING TABLETS
15 MG, 30 MG, AND 45 MG |
TEVA PHARMACEUTICALS USA |
6/28/2005 |
| 24 |
77-196 |
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
TABLETS USP, 100 MG/500 MG |
ANDRX PHARMACEUTICALS, LLC |
6/28/2005 |
| 25 |
77-211 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 750 MG |
RANBAXY LABORATORIES LIMITED |
6/29/2005 |
| 26 |
76-537 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND
400 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
6/30/2005 |
| 27 |
77-034 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
COBALT PHARMACEUTICALS, INC. |
6/30/2005 |
