First-Time Generics - June 2011

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First-Time Generic Approvals - June 2011

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
Pill
Identification
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.09 MG/0.02 MG WATSON LYBREL TABLETS 06-06-11
LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG AUROBINDO LEVAQUIN TABLETS 06-20-11 250 MG - oblong pink T 13; 500 MG - oblong peach T 12; 750 MG - oblong white T 11
LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG SANDOZ LEVAQUIN TABLETS 06-20-11 250 MG - octagonal brown SZ 985; 500 MG - octagonal orange SZ 986; 750 MG - octagonal yellow SZ 987
LEVOFLOXACIN TABLETS, 250 MG AND 500 MG MYLAN LEVAQUIN TABLETS 06-20-11 250 MG - round yellow M 1215; 500 MG - oblong yellow M 1217
LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG TEVA LEVAQUIN TABLETS 06-20-11 250 MG - oval pink Teva 7291; 500 MG - oval peach Teva 7292; 750 MG - oval white Teva 7293
LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG DR. REDDY'S LEVAQUIN TABLETS 06-20-11 250 MG - oblong white RDY 279; 500 MG - oblong orange RDY 280; 750 MG - oblong yellow RDY 281
LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG TORRENT LEVAQUIN TABLETS 06-20-11 250 MG - oblong pink 250 1082; 500 MG - oblong red 83; 750 MG - oblong white 750 1084
LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG WOCKHARDT LEVAQUIN TABLETS 06-20-11 250 MG - oblong pink W 544; 500 MG - oblong peach W 545; 750 MG - oblong white W 547
LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG GLENMARK LEVAQUIN TABLETS 06-20-11
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL ER TABLETS, (OTC) 180 MG/240 MG (24-HOUR FORMULATION) DR. REDDY'S ALLEGRA-D 24 HOUR ER TABLETS 06-22-11 Oblong white RDY 572
FLUCYTOSINE CAPSULES USP, 250 MG AND 500 MG SIGMAPHARM ANCOBON CAPSULES, 250 MG AND 500 MG 06-28-11 250 MG - green & white capsule Σ 9; 500 MG - grey & yellow capsule Σ 10. "Σ" equals upper case Greek sigma symbol

Sources: US Food and Drug Administration, DailyMed and manufacturers' websites