All Product News

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/25 mg, and 10 mg/320 mg/25 mg. Aurobindo’s Amlodipine, Valsartan […]

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 […]

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® […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

AuroMedics, a subsidiary of Aurobindo, will commence marketing the product in April 2017.