|
Office
Of Generic Drugs ANDAs Approvals
May 2000 |
|
|
|
|
|
|
|
|
1 |
. |
75-237 |
SOTALOL
HYDROCHLORIDE |
GENPHARM INC. |
5/1/00 |
|
TABLETS 80 MG 120 MG
160 MG |
|
2 |
. |
75-366 |
SOTALOL
HYDROCHLORIDE |
EON LABS
MANUFACTURING, |
5/1/00 |
|
TABLETS 80 MG 120 MG
160 MG |
INC. |
|
3 |
. |
75-429 |
SOTALOL
HYDROCHLORIDE |
TEVA PHARMACEUTICALS
USA |
5/1/00 |
|
TABLETS 80 MG 120 MG
160 MG |
|
4 |
. |
40-357 |
DIPHENOXYLATE HCL
& |
PAR PHARMACEUTICAL,
INC. |
5/2/00 |
|
ATROPINE SULFATE
TABLETS, |
|
5 |
. |
40-378 |
NIACIN TABLETS, USP
500 MG |
UPSHER-SMITH |
5/3/00 |
|
6 |
. |
75-167 |
RANITIDINE TABLETS,
USP |
TORPHARM INC. |
5/4/00 |
|
7 |
. |
75-520 |
NORTRIPTYLINE |
TARO PHARMACEUTICAL |
5/8/00 |
|
HYDROCHLORIDE
CAPSULES, |
INDUSTRIES, LTD. |
|
USP 10 MG (BASE) 25
MG (BASE) |
|
50 MG (BASE) 75 MG
(BASE) |
|
8 |
. |
75-513 |
AMRINONE INJECTION,
USP 5 |
BEDFORD LABORATORIES |
5/9/00 |
|
9 |
. |
75-629 |
METHYLPHENIDATE |
MALLINCKRODT, INC. |
5/9/00 |
|
EXTENDED-RELEASE
TABLETS, |
|
10 |
. |
75-542 |
AMRINONE INJECTION,
USP 5 |
BAXTER
PHARMACEUTICAL |
5/10/00 |
|
MG/ML (20 ML
SINGLE-DOSE |
PRODUCTS, INC. |
|
11 |
. |
65-003 |
CYCLOSPORINE
CAPSULES, USP |
ABBOTT LABORATORIES |
5/12/00 |
|
(MODIFIED) 25 MG 50
MG 100 |
|
12 |
. |
74-656 |
CISPLATIN INJECTION
1 MG/ |
PHARMACHEMIE B.V. |
5/16/00 |
|
13 |
. |
74-814 |
CISPLATIN INJECTION
1 MG/ML |
GENSIA SICOR |
5/16/00 |
|
14 |
. |
75-633 |
CLOBETASOL
PROPIONATE |
TARO PHARMACEUTICALS
|
5/17/00 |
|
CREAM, USP
(EMOLLIENT) |
U.S.A., INC. |
|
15 |
. |
74-446 |
TERAZOSIN
HYDROCHLORIDE |
NOVOPHARM LIMITED |
5/18/00 |
|
16 |
. |
75-666 |
HYDROCORTISONE
VALERATE |
CLAY-PARK LABS, INC. |
5/24/00 |
|
17 |
. |
65-049 |
CLINDAMYCIN
PHOSPHATE |
CLAY-PARK LABS, INC. |
5/25/00 |
|
(SWABS/PLEDGETS) 1%
(BASE) |
|
18 |
. |
75-592 |
URSODIOL CAPSULES,
USP 300 |
COPLEY
PHARMACEUTICAL, |
5/25/00 |
|
19 |
. |
75-189 |
NABUMETONE TABLETS
500 |
TEVA PHARMACEUTICALS
USA |
5/26/00 |
|
20 |
. |
40-355 |
HYDROCODONE
BITARTRATE |
VINTAGE
PHARMACEUTICALS, |
5/31/00 |
|
& ACETAMINOPHEN
TABLETS, |
INC. |
|
21 |
. |
40-356 |
HYDROCODONE
BITARTRATE |
VINTAGE
PHARMACEUTICALS, |
5/31/00 |
|
& ACETAMINOPHEN
TABLETS, |
INC. |
|
22 |
. |
40-358 |
HYDROCODONE
BITARTRATE |
VINTAGE
PHARMACEUTICALS, |
5/31/00 |
|
& ACETAMINOPHEN
TABLETS, |
INC. |
|
23 |
. |
74-539 |
TAMOXIFEN CITRATE |
PHARMACHEMIE B.V. |
5/31/00 |
|
TABLETS, USP 10 MG
(BASE) |
Back to Top Back to Approvals
FDA/Center for Drug Evaluation and Research
Last Updated: September 10, 200125 Apr 2006 08:52:08 -0400
Originator: OGD
HTML by PKS |