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Chart: FDA's ANDA Approvals

Executive Summary

FDA's ANDA Approvals



FDA's ANDA Approvals

Applicant

Active Ingredients

Number

Date Approved

Sagent Strides

Mesna, 100 mg/mL intravenous inj.

90-913

4/13/2010

Dr Reddy's

Amlodipine besylate/benazepril HCl, EQ 2.5 mg base/10 mg; EQ 5 mg base/10 mg; EQ 5 mg base/20 mg and EQ 10 mg base/20 mg caps.

77-183

4/15/2010

Watson

Metoprolol succinate, EQ 100 mg tartrate and EQ 200 mg tartrate extended-release tabs.

77-298

4/15/2010

Invagen

Carbinoxamine maleate, 4 mg tabs.

90-135

4/15/2010

Emcure

Ondansetron HCl, EQ 2 mg base/mL inj.

90-424

4/16/2010

Lupin

Imipramine pamoate, EQ 75 mg HCl, EQ 100 mg HCl, EQ 125 mg HCl and EQ 150 mg HCl caps.

90-444

4/16/2010

Sagent Strides

Metoprolol tartrate, 1 mg/mL inj.

90-317

4/19/2010

Tentative Approvals

Upsher Smith

Memantine HCl, 5 mg and 10 mg tabs.

90-043

4/15/2010

Aurobindo

Losartan potassium, 25 mg, 50 mg and 100 mg tabs.

90-083

4/15/2010

Orchid

Modafinil, 100 mg and 200 mg tabs.

78-963

4/16/2010

Roxane

Montelukast sodium, 4 mg and 5 mg chewable tabs.

91-128

4/19/2010

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