|
Office Of Generic
Drugs ANDAs Approvals-November 2000
|
|
1 |
. |
75-620 |
MIDAZOLAM |
APOTHECON INC. |
11/1/00 |
|
1 MG (BASE)/ML,
5 MG (BASE)/ML |
|
2 |
. |
75-036 |
CISPLATIN INJECTION
1 MG/ML |
BEDFORD LABORATORIES |
11/7/00 |
|
3 |
. |
75-663 |
SOTALOL
HYDROCHLORIDE |
IMPAX LABORATORIES,
INC. |
11/7/00 |
|
TABLETS 80 MG, 120
MG, 160 MG |
|
4 |
. |
74-713 |
CISPLATIN FOR
INJECTION USP, |
BEDFORD LABORATORIES |
11/14/00 |
|
5 |
. |
75-561 |
CHLORHEXIDINE
GLUCONATE |
NOVEX PHARMA |
11/14/00 |
|
6 |
. |
40-379 |
FLUOROURACIL
INJECTION, |
BIGMAR, INC. |
11/15/00 |
|
7 |
. |
75-643 |
BISOPROLOL FUMARATE |
EON LABS
MANUFACTURING, |
11/16/00 |
|
8 |
. |
75-518 |
MINOXIDIL TOPICAL |
ALPHARMA |
11/17/00 |
|
SOLUTION, USP (FOR
MEN) 5% |
|
9 |
. |
75-619 |
MINOXIDIL TOPICAL |
COPLEY
PHARMACEUTICAL, |
11/17/00 |
|
SOLUTION, USP (FOR
MEN) 5% |
INC. |
|
10 |
. |
40-253 |
ETHOSUXIMIDE SYRUP |
PHARMACEUTICAL |
11/22/00 |
|
250 MG/5 ML |
ASSOCIATES, INC. |
|
11 |
. |
65-053 |
DOXYCYCLINE
CAPSULES, USP |
RANBAXY LABORATORIES
|
11/22/00 |
|
12 |
. |
65-059 |
AMOXICILLIN TABLETS,
USP |
RANBAXY LABORATORIES
|
11/24/00 |
|
13 |
. |
40-395 |
DIPHENOXYLATE |
ABLE LABORATORIES,
INC. |
11/27/00 |
|
ATROPINE SULFATE
TABLETS USP, |
|
14 |
. |
75-703 |
CLEMASTINE FUMARATE |
NOVEX PHARMA |
11/27/00 |
|
SYRUP, 0.5 MG
(BASE)/5 ML |
|
15 |
. |
75-348 |
KETOROLAC
TROMETHAMINE |
APOTHECON, INC. |
11/28/00 |
|
(SYRINGE), 30
MG/ML (SYRINGE) |
|
16 |
. |
65-060 |
AMOXICILLIN TABLETS,
USP |
RANBAXY LABORATORIES
|
11/29/00 |
|
(CHEWABLE) 200 MG,
400 MG |
LIMITED |
|
17 |
. |
75-742 |
RANITIDINE
HYDROCHLORIDE |
CHEMINOR DRUGS
LIMITED |
11/29/00 |
|
18 |
. |
75-888 |
FLUVOXAMINE MALEATE |
EON LABS
MANUFACTURING, |
11/29/00 |
|
TABLETS, 25 MG, 50
MG, 100 MG |
INC. |
|
19 |
. |
75-889 |
FLUVOXAMINE MALEATE |
MYLAN
PHARMACEUTICALS, |
11/29/00 |
|
TABLETS, 25 MG, 50
MG,. 100 MG |
INC. |
|
20 |
. |
65-062 |
MINOCYCLINE |
RANBAXY
PHARMACEUTICALS |
11/30/00 |
|
HYDROCHLORIDE
CAPSULES |
INC. |
|
USP, 50 MG, 75
MG, 100 MG |
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Last Updated: September 10, 200125 Apr 2006 08:53:06 -0400
Originator: OGD
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