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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

Cypress

Ranitidine HCl, EQ 15 mg base/mL syrup

78-684

8/27/2009

Hikma

Cephalexin, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL oral suspension

65-444

8/28/2009

Actavis Totowa

Bicalutamide, 50 mg tabs.

78-634

8/28/2009

Watson

Levonorgestrel, 0.75 mg tabs.

78-665

8/28/2009

Wockhardt

Cetirizine HCl, 5 mg/5 mL syrup

78-757

8/28/2009

Hikma Farmaceutica

Benztropine mesylate, 1 mg/mL inj.

90-287

8/31/2009

Barr

Phentermine HCl, 37.5 mg tabs.

90-470

8/31/2009

Hospira

Heparin sodium, 1,000 units/mL, 5,000 units/mL and 10,000 units/mL inj.

90-571

8/31/2009

Watson

Ethinul estradiol/norethindrone acetate, 0.02 mg/1 mg tabs

78-267

9/1/2009

Tentative Approvals

Cipla

Irbesartan, 75 mg, 150 mg and 300 mg tabs.

77-205

8/31/2009

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