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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - July 2011

 

 

Generic Drug Name

Generic Manufacturer

Brand Name

Approval Date

1

LEVOFLOXACIN AND DEXTROSE (5%) INJECTION, 5 MG/ML; PACKAGED IN 250 MG/50 ML, 500 MG/100 ML AND 750 MG/150 ML SINGLE-USE FLEXIBLE CONTAINERS  

ACS DOBFAR INFO S.A.

LEVAQUIN AND DEXTROSE (5%) INJECTION

7/7/2011 

2

FONDAPARINUX SODIUM INJECTION, 2.5 MG/0.5 ML, 5 MG/0.4 MG, 7.5 MG/0.6 ML AND 10 MG/0.8ML PACKAGED IN PREFILLED SINGLE-DOSE SYRINGES  

DR. REDDY'S LABORATORIES LIMITED

ARIXTRA INJECTION

7/11/2011 

3

MORPHINE SULFATE ORAL SOLUTION, 100 MG/5 ML (20 MG/ML)      

MALLINCKRODT INC.

MORPHINE SULFATE ORAL SOLUTION

7/15/2011 

4

ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG       

TEVA PHARMACEUTICALS USA

UROXATRAL EXTENDED-RELEASE TABLETS

7/18/2011 

5

ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG       

SUN PHARMA GLOBAL FZE

UROXATRAL EXTENDED-RELEASE TABLETS

7/18/2011 

6

ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG       

APOTEX INC.

UROXATRAL EXTENDED-RELEASE TABLETS

7/18/2011 

7

ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG       

TORRENT PHARMACEUTICALS LIMITED

UROXATRAL EXTENDED-RELEASE TABLETS

7/18/2011 

8

ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG       

MYLAN PHARMACEUTICALS, INC.

UROXATRAL EXTENDED-RELEASE TABLETS

7/18/2011 

9

METRONIDAZOLE GEL USP, (TOPICAL) 1%       

TOLMAR INC.

METROGEL 1%

7/22/2011 

10

PARICALCITOL INJECTION USP, 2 MCG/ML AND 5 MCG/ML      

SANDOZ CANADA, INC.

ZEMPLAR INJECTION

7/27/2011 

11

PHENTERMINE RESIN EXTENDED-RELEASE CAPSULES, 15 MG (BASE) AND 30 MG (BASE)      

LANNETT HOLDINGS, INC.

IONAMIN CAPSULES

7/28/2011