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Office of
Generic Drugs Approved Drugs Log - First Time -November 2000
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ANDA No |
Established
Name/Dosage Form and |
Applicant |
SUB
Date |
TA
Date |
AP
Date |
|
74-713 |
CISPLATIN FOR INJECTION USP,
10 MG/VIAL, |
BEDFORD LABORATORIES |
8/18/95 |
11/14/00 |
|
75-643 |
BISOPROLOL FUMARATE TABLETS,
5 MG, 10 MG |
EON LABS MANUFACTURING, INC. |
6/4/99 |
11/16/00 |
|
75-619 |
MINOXIDIL TOPICAL SOLUTION,
USP (FOR MEN) 5% |
COPLEY PHARMACEUTICAL, INC. |
4/16/99 |
11/17/00 |
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75-518 |
MINOXIDIL TOPICAL SOLUTION,
USP (FOR MEN) 5% |
ALPHARMA |
12/7/98 |
11/17/00 |
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75-889 |
FLUVOXAMINE MALEATE TABLETS,
25 MG, 50 MG, |
MYLAN PHARMACEUTICALS, INC. |
6/5/00 |
11/29/00 |
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65-060 |
AMOXICILLIN TABLETS, USP
(CHEWABLE) 200 MG, |
RANBAXY LABORATORIES LIMITED |
12/22/99 |
11/29/00 |
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75-888 |
FLUVOXAMINE MALEATE TABLETS,
25 MG, 50 MG, |
EON LABS MANUFACTURING, INC. |
6/5/00 |
11/29/00 |
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FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:54:33 -0400
Originator: OGD
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