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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

Silarx

Fluoxetine oral solution USP, 20 mg/5 mL

77-849

2/9/2007

Murty

Dipyridamole USP, 25 mg, 50 mg and 75 mg tabs.

40-733

2/13/2007

Actavis Elizabeth

Alprazolam, 0.5 mg, 1 mg, 2 mg and 3 mg extended-release tabs.

78-056

2/13/2007

Mylan

Propranolol HCl, 60 mg, 80 mg, 120 mg and 160 mg extended-release caps.

78-022

2/15/2007

Bedford

Methylprednisolone sodium succinate for inj. USP, 125 mg (base), 500 mg (base) and 1 g (base); packaged in single-dose vials

40-641

2/21/2007

Bedford

Methylprednisolone sodium succinate for inj. USP, 40 mg (base); packaged in single-dose vials

40-662

2/21/2007

Bedford

Methylprednisolone sodium succinate for inj. USP, 500 mg (base) and 1 g (base); packaged in multiple-dose vials

40-709

2/21/2007

Actavis MidAtlantic

Ranitidine oral solution USP, 15 mg/mL

76-124

2/21/2007

Teva

Rabeprazole sodium, 20 mg delayed-release tabs.

76-822

2/21/2007

Corepharma

Zonisamide, 25 mg, 50 mg and 100 mg caps.

77-876

2/21/2007

Tentative Approvals

Roxane

Ropinirole HCl, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg tabs.

77-852

2/9/2007

Sicor

Sumatriptan succinate inj., 6 mg (base)/0.5 mL single-dose vial

77-907

2/13/2007

Watson

Albuterol sulfate and ipratropium bromide inhalation solution, 3 mg (0.083%) and 0.5 mg (0.071%)

77-559

2/21/2007

Taro

Ranitidine syrup (ranitidine oral solution, USP), 15 mg/mL

77-476

2/22/2007

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