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Office Of Generic Drugs ANDAs Approvals
June 2000

1

 . 75-189 NABUMETONE TABLETS 750 TEVA PHARMACEUTICALS USA

6/6/00

MG

2

 . 40-372 PROMETHAZINE ABBOTT LABORATORIES

6/8/00

HYDROCHLORIDE INJECTION,

USP 25 MG/ML (SYRINGE) 50

MG/ML (SYRINGE)

3

 . 40-352 MEPERIDINE HYDROCHLORIDE MALLINCKRODT INC.

6/13/00

TABLETS, USP 50 MG 100 MG

4

 . 75-549 VECURONIUM BROMIDE FOR BEDFORD LABORATORIES

6/13/00

INJECTION 10 MG/VIAL 20

MG/VIAL

5

 . 75-448 ISOSORBIDE MONONITRATE ZENITH GOLDLINE

6/19/00

EXTENDED-RELEASE TABLETS PHARMACEUTICALS, INC.

60 MG

6

 . 75-154 MIDAZOLAM AESGEN, INC.

6/20/00

HYDROCHLORIDE INJECTION 1

MG (BASE)/ML (VIALS) 5 MG

(BASE)/ML (VIALS)

7

 . 75-243 MIDAZOLAM ESI LEDERLE, INC.

6/20/00

HYDROCHLORIDE INJECTION 1

MG (BASE)/ML (VIALS) 5 MG

(BASE)/ML (VIALS)

8

 . 75-293 MIDAZOLAM ABBOTT LABORATORIES

6/20/00

HYDROCHLORIDE INJECTION 1

MG (BASE)/ML (VIALS) 5 MG

(BASE)/ML (VIALS)

9

 . 75-324 MIDAZOLAM BAXTER PHARMACEUTICAL

6/20/00

HYDROCHLORIDE INJECTION 1 PRODUCTS, INC.

MG (BASE)/ML (VIALS) 5 MG

(BASE)/ML (VIALS)

10 . 75-396 MIDAZOLAM FAULDING PHARMACEUTICAL 6/20/00

HYDROCHLORIDE INJECTION 1 CO.

MG (BASE)/ML (VIALS) 5 MG

(BASE)/ML (VIALS)

11 . 75-409 MIDAZOLAM ABBOTT LABORATORIES 6/20/00

HYDROCHLORIDE INJECTION 1

MG (BASE)/ML (SYRINGE) 5 MG

(BASE)/ML (SYRINGE)

12 . 75-421 MIDAZOLAM BEN VENUE LABORATORIES, 6/20/00

HYDROCHLORIDE INJECTION 1 INC.

MG (BASE)/ML (VIALS) 5 MG

(BASE)/ML (VIALS)

13 . 75-455 MIDAZOLAM BEN VENUE LABORATORIES, 6/20/00

HYDROCHLORIDE INJECTION 5 INC.

MG (BASE)/ML (2 ML SYRINGE)


14 . 75-484 MIDAZOLAM FAULDING PHARMACEUTICAL 6/20/00

HYDROCHLORIDE INJECTION 5 CO.

MG (BASE)/ML (SYRINGE)

15 . 40-368 ORPHENADRINE CITRATE IMPAX LABORATORIES, INC. 6/23/00

EXTENDED RELEASE TABLETS

100 MG

16 . 75-247 MIDAZOLAM BEDFORD LABORATORIES 6/23/00

HYDROCHLORIDE INJECTION 1

MG (BASE)/ML (VIALS) 5 MG

(BASE)/ML (VIALS)

17 . 75-249 MIDAZOLAM BEDFORD LABORATORIES 6/23/00

HYDROCHLORIDE INJECTION 5

MG (BASE)/ML (SYRINGE)

18 . 74-732 TAMOXIFEN CITRATE MYLAN PHARMACEUTICALS, 6/26/00

TABLETS, USP 10 MG (BASE) INC.

19 . 75-263 MIDAZOLAM ASTRA-ZENECA 6/26/00

HYDROCHLORIDE INJECTION 5 PHARMACEUTICALS, L.P.

MG (BASE)/ML (SYRINGE)

20 . 65-033 BLEOMYCIN FOR INJECTION, GENSIA SICOR 6/27/00

USP 15 UNITS/VIAL 30 PHARMACEUTICALS, INC.

UNITS/VIAL

21 . 40-246 PROCHLORPERAZINE PADDOCK LABORATORIES, INC. 6/28/00

SUPPOSITORIES, USP 25 MG

22 . 65-032 DOXYCYCLINE CAPSULES, USP EON LABS MANUFACTURING, 6/30/00

50 MG 100 MG INC.

23 . 75-386 BETAXOLOL OPHTHALMIC AKORN, INC. 6/30/00

SOLUTION, USP 0.5%

24 . 75-481 MIDAZOLAM TAYLOR PHARMACEUTICALS 6/30/00

HYDROCHLORIDE INJECTION 5

MG (BASE)/ML (SYRINGE)

25 . 75-494 MIDAZOLAM TAYLOR PHARMACEUTICALS 6/30/00

HYDROCHLORIDE INJECTION 1

MG (BASE)/ML (VIAL) 5 MG

(BASE)/ML (VIAL)

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