Approvals January 2001
|
ANDA NUMBER |
DRUG NAME |
APPLICANT |
APPROVAL DATE |
1 |
65-057 |
CEFACLOR EXTENDED-RELEASE TABLETS USP, 500 MG |
ZENITH GOLDLINE PHARMACEUTICALS, INC. |
1/5/01 |
2 |
75-887 |
FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, 100 MG |
INVAMED INC. |
1/5/01 |
3 |
75-353 |
DOXAZOSIN MESYLATE TABLETS, 1 MG (BASE), 2 MG (BASE), 4 MG (BASE), 8 MG (BASE) |
TEVA PHARMACEUTICALS USA |
1/12/01 |
4 |
75-899 |
FLUVOXAMINE MALEATE TABLETS, 25 MG, 50 MG, 100 MG |
SYNTHON PHARMACEUTICALS LTD. |
1/17/01 |
5 |
75-507 |
IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% |
WARRICK PHARMACEUTICALS |
1/19/01 |
6 |
75-686 |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 MG/6.25 MG, 5 MG/6.25
MG, 10 MG/6.25 MG |
TEVA PHARMACEUTICALS USA |
1/19/01 |
7 |
75-657 |
ENALAPRIL MALEATE TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
1/23/01 |
8 |
75-389 |
AMIODARONE HYDROCHLORIDE TABLETS, 200 MG |
BARR LABORATORIES, INC. |
1/25/01 |
9 |
75-897 |
FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, 100 MG |
BARR LABORATORIES, INC. |
1/25/01 |
10 |
75-051 |
METOCLOPRAMIDE ORAL SOLUTION USP, 5 MG/5 ML |
UDL LABORATORIES, INC. |
1/26/01 |
11 |
75-615 |
CROMOLYN SODIUM OPHTHALMIC SOLUTION USP, 4% |
NOVEX PHARMA |
1/26/01 |
12 |
75-693 |
IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% , |
ASLUNG PHARMACEUTICAL, L.P. |
1/26/01 |
13 |
75-614 |
TERAZOSIN HYDROCHLORIDE CAPSULES, 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), 10 MG (BASE) |
ZENITH GOLDLINE PHARMACEUTICALS, INC. |
1/30/01 |
14 |
75-656 |
MORPHINE SULFATE EXTENDED-RELEASE TABLETS, 100 MG |
WATSON LABORATORIES, INC. |
1/30/01 |
15 |
40-338 |
LEUCOVORIN CALCIUM INJECTION USP, 50 MG (BASE)/VIAL (PRESERVATIVE-FREE) |
LUITPOLD PHARMACEUTICALS, INC. |
1/31/01 |
16 |
40-342 |
PHENYTOIN ORAL SUSPENSION USP, 100 MG/5 ML |
UDL LABORATORIES, INC. |
1/31/01 |
17 |
40-361 |
DEXTROAMPHETAMINE SULFATE TABLETS USP, 5 MG, 10 MG |
BARR LABORATORIES, INC. |
1/31/01 |
18 |
75-845 |
OXAPROZIN TABLETS, 600 MG |
EON LABS MANUFACTURING, INC. |
1/31/01 |
19 |
75-855 |
OXAPROZIN TABLETS, 600 MG |
DR. REDDY'S LABORATORIES LIMITED |
1/31/01 |
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FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OGC
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