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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

Sandoz

Metaxalone, 800 mg tabs.

40-445

3/31/2010

Mylan

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride, 420 gm/bot; 1.48 gm/bot; 5.72 gm/bot; 11.2 gm/bot oral solution

90-409

4/2/2010

Teva

Hydrochlorothiazide/losartan potassium, 12.5 mg/50 mg, 12.5 mg/100 mg and 25 mg/100 mg tabs.

77-157

4/6/2010

Roxane

Hydrochlorothiazide/losartan potassium, 12.5 mg/100 mg and 25 mg/100 mg tabs.

77-732

4/6/2010

Sun

Bupropion HCl, 100 mg, 150 mg and 200 mg extended-release tabs.

78-866

4/6/2010

Torrent

Hydrochlorothiazide/losartan potassium, 12.5 mg/100 mg tabs.

90-528

4/6/2010

Vintage

Amlodipine besylate, EQ 2.5 mg base, EQ 5 mg base and EQ 10 mg base tabs.

78-414

4/7/2010

Aurobindo

Venlafaxine HCl, EQ 25 mg base, EQ 37.5 mg base, EQ 50 mg base, EQ 75 mg base and EQ 100 mg base tabs.

90-555

4/7/2010

Tentative Approvals

Synthon

Amlodipine/valsartan, 5 mg/320 mg and 10 mg/320 mg tabs.

90-144

4/1/2010

Mylan

Memantine HCl, 5 mg and 10 mg tabs.

79-225

4/2/2010

Invagen

Tenofovir disoproxil fumarate, 300 mg tabs.

90-636

4/2/2010

Sandoz

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

77-438

4/5/2010

Upsher

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

90-544

4/7/2010

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