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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. 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


Aurobindo Receives FDA Approval for Carbidopa Tablets, 25 mg

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


Aurobindo Receives FDA Approval for Cinacalcet Hydrochloride Tablets, 30mg, 60mg, and 90mg

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


Aurobindo Receives FDA Approval for Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg

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 (NNitrosodiethylamine) Impurity

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, […]

June 27, 2018


Aurobindo Launched Atazanavir Capsules

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 […]

June 19, 2018


Aurobindo Launched Sildenafil Citrate 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 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. […]

May 11, 2018


Aurobindo Phama has launched its line of Oral Contraceptive tablets Mili™ and Tri-Mili™

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 […]

May 11, 2018


Aurobindo Receives FDA Approval for Capecitabine Tablets USP

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 […]

April 03, 2018


Aurobindo Receives FDA Approval for its line of oral contraceptives, Zumandimine and Lo-Zumandimine.

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 […]

March 26, 2018


Aurobindo Receives FDA Approval for Armodafinil 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 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 […]

March 06, 2018


Aurobindo Receives FDA Approval for Ibuprofen Oral Suspension USP

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 […]