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Office Of Generic Drugs ANDAs Approvals-
September 2000 |
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Page: |
1 |
Friday, October 06, 2000 |
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1 |
. |
40-405 |
HYDROCODONE BITARTRATE |
MALLINCKRODT, INC. |
9/8/00 |
|
TABLETS, USP 7.5 MG/325 MG |
|
2 |
. |
75-411 |
TIMOLOL MALEATE |
NOVEX PHARMA |
9/8/00 |
|
3 |
. |
75-412 |
TIMOLOL MALEATE |
NOVEX PHARMA |
9/8/00 |
|
4 |
. |
65-050 |
CEFOXITIN FOR INJECTION, |
ESI LEDERLE |
9/11/00 |
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5 |
. |
65-051 |
CEFOXITIN FOR INJECTION, |
ESI LEDERLE |
9/11/00 |
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6 |
. |
75-184 |
PACLITAXEL INJECTION 6 |
BAKER NORTON |
9/15/00 |
|
MG/ML |
PHARMACEUTICALS, INC. |
|
7 |
. |
65-056 |
AMOXICILLIN TABLETS, USP |
TEVA PHARMACEUTICALS USA |
9/18/00 |
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8 |
. |
75-287 |
PEMOLINE TABLETS 37.5 MG 75 |
WATSON LABORATOTIES, INC. |
9/18/00 |
|
9 |
. |
75-392 |
PROPOFOL INJECTABLE |
GENSIA SICOR |
9/19/00 |
|
EMULSION 1% (10 MG/ML) |
PHARMACEUTICALS, INC. |
|
10 |
. |
40-397 |
CARISOPRODOL TABLETS, USP |
COREPHARMA LLC |
9/21/00 |
|
11 |
. |
75-469 |
BISOPROLOL FUMARATE AND |
CHELSEA LABORATORIES, INC. |
9/25/00 |
|
12 |
. |
75-527 |
BISOPROLOL FUMARATE AND |
INVAMED INC. |
9/25/00 |
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13 |
. |
75-579 |
BISOPROLOL FUMARATE
AND |
EON LABS
MANUFACTURING, |
9/25/00 |
|
14 |
. |
75-672 |
BISOPROLOL FUMARATE
AND |
PUREPAC
PHARMACEUTICAL |
9/25/00 |
|
15 |
. |
75-768 |
BISOPROLOL FUMARATE
AND |
MYLAN
PHARMACEUTICALS, |
9/25/00 |
|
16 |
. |
75-289 |
NIFEDIPINE |
BIOVAIL
LABORATORIES, INC. |
9/27/00 |
|
EXTENDED-RELEASE
TABLETS, |
|
17 |
. |
75-632 |
BISOPROLOL FUMARATE
AND |
ZENITH GOLDLINE |
9/27/00 |
|
HYDROCHLOROTHIAZIDE |
PHARMACEUTICALS,
INC. |
|
18 |
. |
75-446 |
BETAXOLOL OPHTHALMIC
|
NOVEX PHARMA |
9/28/00 |
|
19 |
. |
40-314 |
TROPICAMIDE
OPHTHALMIC |
AKORN, INC. |
9/29/00 |
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20 |
. |
40-315 |
TROPICAMIDE
OPHTHALMIC |
AKORN, INC. |
9/29/00 |
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21 |
. |
75-103 |
HYDROCODONE
BITRATRATE |
ALPHARMA, U.S. |
9/29/00 |
|
SYRUP 5 MG/5 ML; 25
MG/5 ML |
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FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:52:50 -0400
Originator: OGD
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