July 31, 2020
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Imatinib Mesylate Tablets, 100 mg and 400 mg. Aurobindo’s Imatinib Mesylate Tablets, 100 mg and 400 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Gleevec Tablets, 100 mg […]
July 31, 2020
East Windsor, NJ–Aurobindo Pharma has received approval from the U.S. Food and Drug Administrationfor its Abbreviated New Drug Application Montelukast Sodium Oral Granules USP, 4mg. Aurobindo’s Montelukast Sodium Oral Granules USP, 4 mg are an AB-rated generic equivalent to the reference listed drug (RLD),SINGULAIR® of Merck & Co Inc. They will be available in 4 […]
April 08, 2020
East Windsor, NJ – Aurobindo Pharma has received approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Tizanidine Hydrochloride capsules. Aurobindo’s Tizanidine Hydrochloride capsules are an AB-rated generic that is equivalent to the brand drug Zanaflex® and will be available in 2 mg, 4 mg, and 6 mg dose […]
February 07, 2020
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Trazodone Hydrochloride Tablets, 50 mg, 100 mg, 150 mg, and 300 mg. Aurobindo’s Trazodone Hydrochloride Tablets, 50 mg, 100 mg, 150 mg, and 300 mg are an AB-rated generic equivalent to the […]
February 07, 2020
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL). Aurobindo’s Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 […]
February 07, 2020
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Methotrexate Tablets USP, 2.5 mg. Aurobindo’s Methotrexate Tablets USP, 2.5 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Rheumatrex Tablets, 2.5 mg, of DAVA Pharmaceuticals, Inc. Methotrexate Tablets […]
December 30, 2019
Aurobindo Pharma USA, Inc. Contact – 1-866-850-2876 option 2 Recall returns being handled by: Qualanex: Contact 1-888-504-2014 FOR IMMEDIATE RELEASE – December 30, 2019 – East Windsor, NJ, Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error […]
November 06, 2019
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL due to the detection of NDMA (Nitrosodimethylamine) Impurity Aurobindo Pharma USA, Inc. contact {1-866-850-2876 option 2} Recall being handled by: Qualanex: Contact 1-888-504-2014 FOR IMMEDIATE RELEASE November 6, […]
October 30, 2019
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Carbidopa Tablets, 25 mg. Aurobindo’s Carbidopa Tablets, 25 mg are an AB-rated generic equivalent to the reference listed drug, Bausch Health Americas, Inc.’s Lodosyn® Tablets, 25mg. Carbidopa Tablets are indicated for use […]
August 20, 2019
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Cinacalcet Hydrochloride Tablets, 30mg, 60mg, and 90mg. Aurobindo’s Cinacalcet Hydrochloride Tablets are an AB-rated generic equivalent to the reference listed drug, Amgen Inc’s Sensipar. Cinacalcet Hydrochloride tablets are indicated for the […]
August 09, 2019
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg. Aurobindo’s Fenofibric Acid Delayed-Release Capsules is an AB-rated generic equivalent to the reference listed drug, Abbvie Inc.’s TRILIPIX®. Fenofibric Acid Delayed-Release Capsules […]
February 28, 2019
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, […]