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FDA’s ANDA Approvals

Applicant

Active Ingredients

Number

Date Approved

Glenmark

Norgestimate; ethinyl estradiol; 0.18 mg and 0.035 mg; 0.215 mg and 0.035 mg; 0.25 mg and 0.035 mg tabs.

200-494

6/17/2011

Sun

Sumatriptan succinate; EQ 6 mg base/0.5mL (EQ 12 mg base/mL) inj.

90-358

6/21/2011

Mylan

Levofloxacin; 250 mg and 500 mg tabs.

76-276

6/20/2011

Teva

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

76-361

6/20/2011

Dr Reddy's

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

76-710

6/20/2011

Mylan

Levofloxacin; 750 mg tabs.

77-097

6/20/2011

Sandoz

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

77-438

6/20/2011

Lupin

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

78-424

6/20/2011

Wockhardt

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

90-367

6/20/2011

Torrent

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

90-722

6/20/2011

Akorn

Levofloxacin; EQ 500 mg/20mL (EQ 25 mg/mL); EQ 750 mg/30mL (EQ 25 mg/mL) inj.

91-644

6/20/2011

Hi Tech

Levofloxacin; 250 mg/10 mL oral solution.

91-678

6/20/2011

Glenmark

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

200-250

6/20/2011

Sagent

Levofloxacin; EQ 500 mg/20 mL (EQ 25 mg/mL); EQ 750 mg/30 mL (EQ 25 mg/mL) inj.

200-560

6/20/2011

Aurobindo

Levofloxacin; 250 mg, 500 mg and 750 mg tabs.

201-043

6/20/2011

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