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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

Healthpoint

Clobetasol Propionate 0.05%, gel

76-141

4/12/02

USL Pharma

Estradiol USP 0.5 mg, 1 mg, and 2 mg, tab.

40-297

4/17/02

Geneva

Amoxicillin and clavulanate potassium USP (chewable )200 mg/28.5 mg (base), and 400 mg/57 mg (base), respectively, tab.

65-065

4/18/02

Morton Grove

Phenytoin USP 125 mg/5 mL, oral suspension.

40-420

4/19/02

Vintage

Butalbital, acetaminophen, caffeine & codeine phos. 50 mg/325 mg/40 mg/30 mg, capsule

75-929

4/22/02

Torpharm

Metformin HCl 500 mg, 850 mg and 1,000 mg, tab.

75-984

4/23/02

Tentative Approvals

Andrx

Metformin HCl 500 mg, extended-release tab.

76-172

4/18/02

Barr

Alendronate sodium 35 mg and 70 mg, tab.

76-184

4/23/02

Par

Zolpidem tartrate 5 mg and 10 mg, tab.

76-062

4/26/02

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