01

Dec 2017

Aurobindo Receives FDA Approval for Quetiapine Fumarate Extended Release Tablets.

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300mg and 400mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Quetiapine Fumarate Extended-Release Tablets 50 mg, 150 mg, 200 mg, 300 mg, and 400... Read more

30

Oct 2017

Aurobindo Receives FDA Approval for Prasugrel Tablets, 5 mg and 10mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Prasugrel Tablets, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Prasugrel Tablets, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Effient®... Read more

11

Oct 2017

Aurobindo Receives FDA Approval for Ezetimibe Tablets USP, 10 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ezetimibe Tablets USP, 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Ezetimibe Tablets USP, 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug ZETIA®. Ezetimibe is indicated as... Read more

11

Oct 2017

Aurobindo Receives FDA Approval for Moxifloxacin Ophthalmic Soln. 0.5%.

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Moxifloxacin Ophthalmic Soln. 0.5%. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Moxifloxacin Ophthalmic Soln. 0.5%. to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Vigamox® Moxifloxacin Ophthalmic Solution is indicated as... Read more

19

Jul 2017

Aurobindo Receives FDA Approval for Sevelamer Carbonate Tablets, 800 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Sevelamer Carbonate Tablets, 800 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Sevelamer Carbonate Tablets, 800 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Renvela®. Sevelamer Carbonate is a... Read more

31

May 2017

Aurobindo Pharma receives USFDA Approval for Atomoxetine Capsules

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Atomoxetine capsules, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg. Atomoxetine capsules are the AB rated generic equivalent of Eli Lilly and Company’s Strattera... Read more

22

May 2017

Aurobindo Receives FDA Approval for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent... Read more

22

May 2017

Aurobindo Receives FDA Approval for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5... Read more

01

May 2017

Aurobindo Receives FDA Approval for Olmesartan Medoxomil and Hydrochlorothiazide Tablets

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and... Read more

01

May 2017

Aurobindo Receives FDA Approval for Olmesartan Medoxomil Tabs, 5, 20, & 40 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg to be bioequivalent and, therefore, therapeutically equivalent... Read more