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September 08, 2025


Aurobindo Receives FDA Approval for Prochlorperazine Maleate Tablets USP, 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 Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg. Aurobindo Pharma’s Prochlorperazine Maleate Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Compazine Tablets manufactured by GlaxoSmithKline (GSK) Prochlorperazine […]

September 08, 2025


Aurobindo Receives FDA Approval for Deferasirox Oral Granules, 90 mg,180 mg, and 360 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 Deferasirox Oral Granules, 90 mg,180 mg, and 360 mg. Aurobindo Pharma’s Deferasirox Oral Granules, are an AB-rated generic equivalent to the reference listed drug (RLD), Jadenu Sprinkle Granules manufactured by Novartis Pharmaceuticals […]

August 11, 2025


Aurobindo Receives FDA Approval for Pirfenidone Tablets USP, 267 mg and 801 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 Tablets USP, 267 mg and 801 mg. Aurobindo Pharma’s Pirfenidone Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Esbriet Tablets manufactured by Genentech Inc. (a subsidiary of […]

July 29, 2025


Aurobindo Receives FDA Approval for Lidocaine Hydrochloride Oral Topical Solution USP, 2%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lidocaine Hydrochloride Oral Topical Solution USP, 2%. Aurobindo Pharma’s Lidocaine Hydrochloride Oral Topical Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Xylocaine Oral Topical Solution manufactured by Fresenius […]

July 17, 2025


Aurobindo Receives FDA Approval for Furosemide Tablets USP, 20 mg, 40 mg, and 80 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 Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg. Aurobindo Pharma’s Furosemide Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Lasix Tablets manufactured by Validus Pharmaceuticals LLC. […]

July 09, 2025


Aurobindo Receives FDA Approval for Metronidazole Topical Cream, 0.75%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Metronidazole Topical Cream, 0.75%. Aurobindo Pharma’s Metronidazole Topical Cream, are an AB-rated generic equivalent to the reference listed drug (RLD), MetroCream Topical Cream manufactured by Galderma Laboratories, L.P. Metronidazole Topical Cream are […]

July 09, 2025


Aurobindo Receives FDA Approval for Famotidine for Oral Suspension USP, 40 mg/5 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 Famotidine for Oral Suspension USP, 40 mg/5 mL. Aurobindo Pharma’s Famotidine for Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Pepcid for Oral Suspension manufactured by Salix […]

June 30, 2025


Aurobindo Receives FDA Approval for Ibuprofen and Famotidine Tablets, 800 mg/26.6 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 Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg. Aurobindo Pharma’s Ibuprofen and Famotidine Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Duexis® Tablets manufactured by Horizon Medicines LLC. Ibuprofen […]

June 09, 2025


Aurobindo Receives FDA Approval for Sapropterin Dihydrochloride Tablets, 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 Sapropterin Dihydrochloride Tablets, 100 mg. Aurobindo Pharma’s Sapropterin Dihydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Kuvan Tablets manufactured by BioMarin Pharmaceutical Inc. Sapropterin Dihydrochloride Tablets are […]

May 30, 2025


Aurobindo Receives FDA Approval for Acetazolamide Tablets USP, 125 mg and 250 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 Acetazolamide Tablets USP, 125 mg and 250 mg. Aurobindo Pharma’s Acetazolamide Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Diamox Tablets manufactured by Teva Branded Pharmaceutical Products R&D […]

May 14, 2025


Aurobindo Receives FDA Approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 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 Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. Aurobindo Pharma’s Dabigatran Etexilate Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Pradaxa Capsules manufactured by Boehringer Ingelheim […]

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 […]