Product News Archives | Aurobindo Pharma USA

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June 03, 2026


Aurobindo Receives FDA Approval for Tofacitinib Tablets, 5 mg and 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 Tofacitinib Tablets, 5 mg and 10 mg. Aurobindo Pharma’s Tofacitinib Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Xeljanz Tablets, manufactured by PF Prism C.V. Tofacitinib Tablets are […]

June 02, 2026


Aurobindo Receives FDA Approval for Eluxadoline Tablets, 75 mg and 100 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 Eluxadoline Tablets, 75 mg and 100 mg. Aurobindo Pharma’s Eluxadoline Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Viberzi Tablets, manufactured by AbbVie Inc. Eluxadoline Tablets are indicated […]

April 20, 2026


Aurobindo Receives FDA Approval for Canagliflozin Tablets, 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 Canagliflozin Tablets, 100 mg and 300 mg. Aurobindo Pharma’s Canagliflozin Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Invokana Tablets, manufactured by Janssen Pharmaceuticals, Inc. Canagliflozin Tablets are […]

April 20, 2026


Aurobindo Receives FDA Approval for Pirfenidone Capsules USP, 267 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 Pirfenidone Capsules USP, 267 mg. Aurobindo Pharma’s Pirfenidone Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Esbriet Capsules, manufactured by Legacy Pharma, Inc. Pirfenidone Capsules are indicated for […]

April 15, 2026


Aurobindo Receives FDA Approval for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. Aurobindo Pharma’s Glycerol Phenylbutyrate Oral Liquid, are an AB-rated generic equivalent to the reference listed drug (RLD), Ravicti Oral Liquid, manufactured by Horizon Therapeutics […]

April 06, 2026


Aurobindo Receives FDA Approval for Dapagliflozin Tablets, 5 mg and 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 Dapagliflozin Tablets, 5 mg and 10 mg. Aurobindo Pharma’s Dapagliflozin Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Farxiga Tablets, manufactured by AstraZeneca AB. Dapagliflozin Tablets are indicated […]

April 06, 2026


Aurobindo Receives FDA Approval for Dapagliflozin and Metformin Hydrochloride Extended- Release Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 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 Dapagliflozin and Metformin Hydrochloride Extended- Release Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg. Aurobindo Pharma’s Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, are an AB-rated […]

March 23, 2026


Aurobindo Receives FDA Approval for Cefixime Capsules, 400 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 Cefixime Capsules. Aurobindo Pharma’s Cefixime Capsules, is an AB-rated generic equivalent to the reference listed drug (RLD), Suprax® Capsules, manufactured by Lupin Limited. Cefixime Capsules, 400 mg are indicated in the treatment […]

March 18, 2026


Aurobindo Receives FDA Approval for Clindamycin Phosphate Gel USP, 1%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Clindamycin Phosphate Gel. Aurobindo Pharma’s Clindamycin Phosphate Gel, is an AB-rated generic equivalent to the reference listed drug (RLD), Cleocin®  T Gel, manufactured by Pfizer Inc. Clindamycin Phosphate Gel are indicated: In […]

March 16, 2026


Aurobindo Receives FDA Approval for Citalopram Capsules, 30 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 Citalopram Capsules, 30 mg. Aurobindo Pharma’s Citalopram Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Citalopram Capsules manufactured by Almatica Pharma, LLC . Citalopram Capsules are indicated for: […]

March 10, 2026


Aurobindo Receives FDA Approval for Siponimod Tablets, 0.25mg, 1mg, and 2mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Siponimod Tablets, 0.25mg, 1mg, and2 mg . Aurobindo Pharma’s Siponimod Tablets are an AB-rated generic equivalent to the reference listed drug (RLD), Mayzent®  Tablets manufactured by Novartis Pharmaceuticals Corporation. Siponimod Tablets are […]