|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
76-447 |
FEXOFENADINE HYDROCHLORIDE TABLETS, 30
MG, 60 MG, AND 180 MG |
TEVA PHARMACEUTICALS, USA |
9/1/2005 |
2 |
77-113 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, 750 MG |
MYLAN PHARMACEUTICALS, INC. |
9/8/2005 |
3 |
77-353 |
ALLOPURINOL TABLETS USP, 100 MG AND 300
MG |
APOTEX INC. |
9/8/2005 |
4 |
77-483 |
BENAZEPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS, 5 MG/6.25 MG, 10 MG/12.5 MG,
20 MG/12.5 MG, AND 20 MG/25 MG |
RANBAXY LABORATORIES LIMITED |
9/8/2005 |
5 |
77-115 |
MIDAZOLAM HYDROCHLORIDE SYRUP, 2 MG
(BASE)/ML |
APOTEX INC. |
9/9/2005 |
6 |
77-321 |
LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10
MG, 20 MG, 30 MG, AND 40 MG |
LUPIN LIMITED |
9/9/2005 |
7 |
76-650 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, 500 MG |
MYLAN PHARMACEUTICALS, INC. |
9/13/2005 |
8 |
76-985 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, 750 MG |
IMPAX LABORATORIES, INC. |
9/13/2005 |
9 |
77-083 |
LEFLUNOMIDE TABLETS, 10 MG AND 20 MG |
BARR LABORATORIES, INC. |
9/13/2005 |
10 |
77-084 |
LEFLUNOMIDE TABLETS, 10 MG AND 20 MG |
TEVA PHARMACEUTICALS USA |
9/13/2005 |
11 |
77-085 |
LEFLUNOMIDE TABLETS, 10 MG AND 20 MG |
SANDOZ, INC. |
9/13/2005 |
12 |
77-086 |
LEFLUNOMIDE TABLETS, 10 MG AND 20 MG |
KALI LABORATORIES, INC. |
9/13/2005 |
13 |
77-087 |
LEFLUNOMIDE TABLETS, 10 MG AND 20 MG |
SANDOZ, INC. |
9/13/2005 |
14 |
77-090 |
LEFLUNOMIDE TABLETS, 10 MG AND 20 MG |
APOTEX, INC. |
9/13/2005 |
15 |
76-605 |
GABAPENTIN TABLETS, 60O MG AND 800 MG |
RANBAXY LABORATORIES LIMITED |
9/14/2005 |
16 |
76-498 |
TRETINOIN CREAM USP (EMOLLIENT), 0.05% |
SPEAR PHARMACEUTICALS |
9/15/2005 |
17 |
76-587 |
ALCLOMETASONE DIPROPIONATE CREAM USP,
0.05% |
TARO PHARMACEUTICALS USA, INC. |
9/15/2005 |
18 |
77-314 |
NIZATIDINE CAPSULES USP, 150 MG AND 300
MG |
DR. REDDY'S LABORATORIES LIMITED |
9/15/2005 |
19 |
40-590 |
ERGOTAMINE TARTRATE AND CAFFEINE TABLETS
USP, 1 MG/100 MG |
MIKART, INC. |
9/16/2005 |
20 |
76-844 |
ZIDOVUDINE TABLETS USP, 300 MG |
ROXANE LABORATORIES, INC. |
9/19/2005 |
21 |
77-267 |
ZIDOVUDINE TABLETS USP, 300 MG |
AUROBINDO PHARMA LIMITED |
9/19/2005 |
22 |
77-268 |
ZIDOVUDINE ORAL SOLUTION USP, 50 MG/5 ML
|
AUROBINDO PHARMA LIMITED |
9/19/2005 |
23 |
77-327 |
ZIDOVUDINE TABLETS USP, 300 MG |
RANBAXY LABORATORIES LIMITED |
9/19/2005 |
24 |
77-139 |
CARBOPLATIN INJECTION, 10 MG/ML; 5 ML, 15
ML, 45 ML, AND 60 ML VIALS |
SICOR PHARMACEUTICALS, INC. |
9/21/2005 |
25 |
65-170 |
MUPIROCIN OINTMENT USP, 2 % |
TARO PHARMACEUTICALS U.S.A., INC. |
9/23/2005 |
26 |
75-677 |
ACYCLOVIR CAPSULES USP, 200 MG |
APOTEX INC. |
9/28/2005 |
27 |
76-957 |
FLUCONAZOLE TABLETS, 50 MG, 100 MG, AND
200 MG |
UNIQUE PHARMACEUTICAL LABORATORIES |
9/28/2005 |
28 |
76-961 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TABLETS, 10 MG/12.5 MG AND 20 MG/12.5 MG |
SANDOZ INC. |
9/28/2005 |
29 |
77-246 |
DANAZOL CAPSULES USP, 200 MG |
LANNETT HOLDINGS, INC. |
9/28/2005 |
30 |
77-442 |
PSEUDOEPHEDRINE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS USP, 120 MG |
RANBAXY LABORATORIES LIMITED |
9/28/2005 |
31 |
40-626 |
PRIMIDONE TABLETS USP, 50 MG AND 250 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
9/29/2005 |
32 |
77-309 |
ACYCLOVIR TABLETS USP, 400 MG AND 800 MG
|
APOTEX INC. |
9/29/2005 |