|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
76-220 |
OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG
|
RANBAXY LABORATORIES LIMITED |
9/2/2003 |
2 |
76-093 |
OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG
|
PAR PHARMACEUTICAL, INC. |
9/2/2003 |
3 |
76-182 |
OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG
|
TEVA PHARMACEUTICALS USA |
9/2/2003 |
4 |
75-958 |
MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML
|
HI-TECH PHARMACAL CO., INC. |
9/4/2003 |
5 |
76-094 |
PERGOLIDE MESYLATE TABLETS, USP 0.05 MG
(BASE), 0.25 MG (BASE), AND 1 MG (BASE) |
IVAX PHARMACEUTICALS S.R.O. |
9/4/2003 |
6 |
76-163 |
AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML;
PACKAGED IN 150 MG/3 ML, 450 MG/9 ML, AND 900 MG/18 ML
SINGLE-USE VIALS |
SICOR PHARMACEUTICALS, INC. |
9/5/2003 |
7 |
40-535 |
OXYCODONE AND ACETAMINOPHEN TABLETS, USP 7.5
MG/325 MG AND 10 MG/325 MG |
WATSON LABORATORIES, INC. |
9/5/2003 |
8 |
76-514 |
MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG AND 5
MG |
EON LABS, INC. |
9/11/2003 |
9 |
76-467 |
GLIPIZIDE EXTENDED-RELEASE TABLETS 5 MG
|
WATSON LABORATORIES, INC. |
9/8/2003 |
10 |
40-480 |
AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS
(MIXED SALTS) 5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG,
AND 30 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
9/9/2003 |
11 |
40-313 |
PREDNISOLONE SYRUP, USP 15 MG/5 ML |
MORTON GROVE PHARMACEUTICALS, INC. |
9/10/2003 |
12 |
76-429 |
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
TABLETS, USP 100 MG/500 MG |
AAI PHARMA |
9/10/2003 |
13 |
76-577 |
MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG,
AND 10 MG |
MYLAN PHARMACEUTICALS, INC. |
9/10/2003 |
14 |
76-254 |
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2%
|
ALCON INC. |
9/16/2003 |
15 |
76-302 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100
MG, 150 MG, 200 MG, AND 250 MG |
EON LABS, INC. |
9/16/2003 |
16 |
65-100 |
CEPHALEXIN TABLETS FOR ORAL SUSPENSION 125 MG
AND 250 MG |
RANBAXY LABORATORIES LIMITED |
9/11/2003 |
17 |
75-350 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400
MG |
PUREPAC PHARMACEUTICAL CO. |
9/12/2003 |
18 |
75-145 |
SELEGILINE HYDROCHLORIDE CAPSULES 5 MG |
AAI PHARMA |
9/15/2003 |
19 |
75-763 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100
MG, 150 MG, 200 MG, AND 250 MG |
IVAX PHARMACEUTICALS, INC. |
9/16/2003 |
20 |
76-072 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100
MG, 150 MG, 200 MG, AND 250 MG |
GENEVA PHARMACEUTICALS, INC. |
9/16/2003 |
21 |
76-409 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100
MG, 150 MG, 200 MG, AND 250 MG |
RANBAXY LABORATORIES LIMITED |
9/16/2003 |
22 |
76-037 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100
MG, 150 MG, 200 MG, AND 250 MG |
TEVA PHARMACEUTICALS USA |
9/16/2003 |
23 |
76-309 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100
MG, 150 MG, 200 MG, AND 250 MG |
DR. REDDY'S LABORATORIES LIMITED |
9/16/2003 |
24 |
76-196 |
NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100
MG, 150 MG, 200 MG, AND 250 MG |
ROXANE LABORATORIES, INC. |
9/16/2003 |
25 |
76-129 |
NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150
MG, 200 MG, AND 250 MG |
MYLAN PHARMACEUTICALS, INC. |
9/16/2003 |
26 |
76-073 |
NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150
MG, 200 MG, AND 250 MG |
WATSON LABORATORIES, INC. |
9/16/2003 |
27 |
76-206 |
CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML)
|
LYNE LABORATORIES, INC. |
9/17/2003 |
28 |
76-064 |
NORETHINDRONE ACETATE & ETHINYL ESTRADIOL
TABLETS, USP & F 1.5 MG/30 MCG (WITH FERROUS FUMARATE,
75 MG) |
BARR LABORATORIES, INC. |
9/18/2003 |
29 |
76-081 |
NORETHINDRONE ACETATE & ETHINYL ESTRADIOL
TABLETS, USP & FER 1 MG/20 MCG (AND FERROUS FUMARATE, 75
MG) |
BARR LABORATORIES, INC. |
9/18/2003 |
30 |
40-451 |
CYANOCOBALAMIN INJECTION, USP 1,000 MCG/ML (1
MG/ML) PACKAGED IN 10 ML MULTIPLE-DOSE VIALS. |
PHARMAFORCE, INC. |
9/23/2003 |
31 |
65-124 |
CEFOTAXIME FOR INJECTION, USP 500 MG, 1 G,
AND 2 G/VIAL |
LUPIN LIMITED |
9/24/2003 |
32 |
40-482 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL
SOLUTION 7.5 MG/325 MG PER 15 ML |
MIKART INC. |
9/25/2003 |
33 |
76-290 |
LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5%
|
HI-TECH PHARMACAL CO., INC. |
9/25/2003 |
34 |
75-746 |
CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML)
AND 0.002 MG/ML (2 MCG/ML) PACKAGED IN 1 ML SINGLE-USE
AMPULES |
LUITPOLD PHARMACEUTICALS, INC. |
9/26/2003 |
35 |
76-525 |
CARBAMAZEPINE TABLETS, USP 200 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
9/26/2003 |
36 |
76-011 |
LORATADINE ORALLY DISINTEGRATING TABLETS
(OTC) 10 MG |
IMPAX LABORATORIES, INC. |
9/29/2003 |
37 |
65-125 |
CEFTRIAXONE FOR INJECTION, USP 250 MG, 500
MG, 1 G, AND 2 G/SINGLE-USE VIAL |
LUPIN LIMITED |
9/30/2003 |
38 |
40-472 |
AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS
(MIXED SALTS) 5 MG, 10 MG, 20 MG, AND 30 MG |
ABRIKA PHARMACEUTICALS, LLLP |
9/30/2003 |
39 |
40-537 |
CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP 4
MG |
COREPHARMA LLC |
9/30/2003 |
40 |
76-416 |
TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE)
AND 4 MG (BASE) |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
9/29/2003 |
41 |
40-518 |
BETHANECHOL CHLORIDE TABLETS, USP 50 MG
|
WOCKHARDT LIMITED |
9/29/2003 |
42 |
40-532 |
BETHANECHOL CHLORIDE TALBETS, USP 5 MG |
WOCKHARDT LIMITED |
9/29/2003 |
43 |
40-534 |
BETHANECHOL CHLORIDE TABLETS, USP 25 MG
|
WOCKHARDT LIMITED |
9/29/2003 |
44 |
40-533 |
BETHANECHOL CHLORIDE TABLETS 10 MG |
WOCKHARDT LIMITED |
9/29/2003 |