All Product News

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 39 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity. AurobindoPharma USA, Inc. contact 1-866-850-2876 Option 2 Recall being handled by: Inmar\CLS-Medturn contact 1-877-208-2407 Acetris returns partner contact 888-280-2043 FOR IMMEDIATE RELEASE: 03/01/19: AurobindoPharma USA, […]

East Windsor, N.J. – Aurobindo Pharma Limited has launched Atazanavir Capsules 100 mg, 150 mg, 200 mg, and 300 mg upon receiving final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Aurobindo’s Atazanavir Capsules are an AB-rated generic equivalent to the reference listed drug REYATAZ®. Atazanavir capsules 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 Sildenafil Tablets, 25mg, 50mg, and 100mg. Aurobindo’s Sildenafil Tablets are an AB-rated generic equivalent to the reference listed drug VIAGRA®. Sildenafil Citrate tablets is indicated for the treatment of erectile dysfunction. […]

East Windsor, N.J. – Aurobindo Pharma Limited is set to launch Mili™ and Tri-Mili™ lines of oral contraceptive tablets June 2018. Aurobindo’s Mili™ and Tri-Mili™ are an AB-rated generic equivalent to the reference listed drugs Ortho Cyclen® and Ortho Tri-Cyclen®. Please see below table for specific product information. Product Name Strength Brand Equivalent Mili™ Norgestimate […]

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 […]