Product News Archives | Aurobindo Pharma USA

Currently Browsing

All Product News

May 02, 2025


Aurobindo Receives FDA Approval for Varenicline Tablets, 0.5 mg and 1 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 Varenicline Tablets, 0.5 mg and 1 mg. Aurobindo Pharma’s Varenicline Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Chantix Tablets manufactured by PF Prism C.V. Varenicline Tablets are […]

April 30, 2025


Aurobindo Receives FDA Approval for Oxcarbazepine Extended-Release Tablets, 150 mg, 300 mg, and 600 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 Oxcarbazepine Extended-Release Tablets, 150 mg, 300 mg, and 600 mg. Aurobindo Pharma’s Oxcarbazepine Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Oxtellar XR Tablets manufactured by Supernus […]

April 25, 2025


Aurobindo Receives FDA Approval for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 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 Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg. Aurobindo Pharma’s Chlorpromazine Hydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Chlorpromazine […]

April 15, 2025


Aurobindo Receives FDA Approval for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 10 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 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 10 mg. Aurobindo Pharma’s Esomeprazole Magnesium for Delayed-Release Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Nexium for Delayed-Release Oral Suspension […]

April 15, 2025


Aurobindo Receives FDA Approval for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 5 mg, 20 mg, and 40 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 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 5 mg, 20 mg, and 40 mg. Aurobindo Pharma’s Esomeprazole Magnesium for Delayed-Release Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), […]

April 14, 2025


Aurobindo Receives FDA Approval for Allopurinol Tablets USP, 100 mg and 300 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 Allopurinol Tablets USP, 100 mg and 300 mg. Aurobindo Pharma’s Allopurinol Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Zyloprim Tablets manufactured by Casper Pharma LLC. Allopurinol Tablets […]

April 10, 2025


Aurobindo Receives FDA Approval for Rivaroxaban Tablets USP, 2.5 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 Rivaroxaban Tablets USP, 2.5 mg. Aurobindo Pharma’s Rivaroxaban Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Xarelto Tablets manufactured by Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban Tablets are indicated: […]

April 04, 2025


Aurobindo Receives FDA Approval for Dapsone Gel, 5%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dapsone Gel, 5%. Aurobindo Pharma’s Dapsone Gel, are an AB-rated generic equivalent to the reference listed drug (RLD), Aczone Gel manufactured by AbbVie Inc. Dapsone Gel are indicated for the: Topical treatment […]

March 31, 2025


Aurobindo Receives FDA Approval for Pantoprazole Sodium for Delayed-Release Oral Suspension, 40 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 Pantoprazole Sodium for Delayed-Release Oral Suspension, 40 mg. Aurobindo Pharma’s Pantoprazole Sodium for Delayed-Release Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Protonix for Delayed-Release Oral Suspension […]

March 21, 2025


Aurobindo Receives FDA Approval for Nystatin Cream USP, 100,000 units per gram

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Nystatin Cream USP, 100,000 units per gram. Aurobindo Pharma’s Nystatin Cream, are an AB-rated generic equivalent to the reference listed drug (RLD), Nystatin Cream manufactured by Taro Pharmaceuticals Inc., Nystatin Cream are […]

February 27, 2025


Aurobindo Receives FDA Approval for Tretinoin Gel USP, 0.025%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Tretinoin Gel USP, 0.025%. Aurobindo Pharma’s Tretinoin Gel, are an AB-rated generic equivalent to the reference listed drug (RLD), Retin-A® Gel manufactured by Bausch Health US, LLC. Tretinoin Gel are indicated for: […]

January 13, 2025


Aurobindo Receives FDA Approval for Tretinoin Gel USP, 0.01%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Tretinoin Gel USP, 0.01%. Aurobindo Pharma’s Tretinoin Gel, are an AB-rated generic equivalent to the reference listed drug (RLD), Retin-A® Gel manufactured by Bausch Health US, LLC. Tretinoin Gel are indicated for: […]