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 Capecitabine Tablets USP, 150 mg and 500 mg. Aurobindo’s Capecitabine Tablets USP is an AB-rated generic equivalent to the reference listed drug XELODA®. Capecitabine Tablets USP is indicated for the […]

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 Zumandimine™ and Lo-Zumandimine™ lines of OC tablets. Aurobindo’s Zumandimine™ and Lo-Zumandimine™ are an AB-rated generic equivalent to the reference listed drugs YAZ® and YASMIN®. Please see table below for each […]

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 Armodafinil Tablets, 50 mg, 150 mg, and 250 mg. Aurobindo’s Armodafinil tablets are an AB-rated generic equivalent to the reference listed drug NUVIGIL®. Armodafinil tablets are indicated to improve wakefulness in adult patients […]

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 Ibuprofen Oral Suspension USP, 100 mg/5 mL. Aurobindo’s Ibuprofen Oral Suspension USP are an AB-rated generic equivalent to the reference listed drug Motrin® Oral Suspension. Ibuprofen Oral Suspension is indicated […]

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 Sumatriptan and Naproxen Sodium Tablets, 85 mg/500 mg. Aurobindo’s Sumatriptan and Naproxen Sodium Tablets are an AB-rated generic equivalent to the reference listed drug Treximet®. Sumatriptan and Naproxen Sodium tablets […]

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 Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1000 mg. Aurobindo’s Niacin Extended-Release Tablets USP are an AB-rated generic equivalent to the reference listed drug NIASPAN®. Niacin Extended-Release tablets […]

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 Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg, and 300 mg. Aurobindo’s Tenofovir Disoproxil Fumarate Tablets are an AB-rated generic equivalent to the reference listed drug VIREAD®. Tenofovir […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Lorazepam Tablets USP to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Ativan®. Lorazepam […]

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 […]