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March 18, 2024


Aurobindo Receives FDA Approval for Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray. Aurobindo Pharma’s Mometasone Furoate Monohydrate Nasal Spray, are an AB-rated generic equivalent to the reference listed drug (RLD), Nasonex Nasal Spray manufactured by Organon LLC. […]

February 28, 2024


Aurobindo Receives FDA Approval for Fingolimod Capsules, 0.5 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 Fingolimod Capsules, 0.5 mg. Aurobindo Pharma’s Fingolimod Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Gilenya Capsules manufactured by Novartis Pharmaceuticals Corporation. Fingolimod Capsules are indicated for: The […]

February 27, 2024


Aurobindo Receives FDA Approval for Mycophenolic Acid Delayed-Release Tablets USP, 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 Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg. Aurobindo Pharma’s Mycophenolic Acid Delayed-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Myfortic Delayed-Release Tablets manufactured by […]

February 20, 2024


Aurobindo Receives FDA Approval for Mycophenolate Mofetil Tablets USP, 500 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 Mycophenolate Mofetil Tablets USP, 500 mg. Aurobindo Pharma’s Mycophenolate Mofetil Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Cellcept Tablets manufactured by Roche Palo Alto LLC. Mycophenolate Mofetil […]

February 13, 2024


Aurobindo Receives FDA Approval for Atorvastatin Calcium Tablets USP, 10 mg, 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 Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg. Aurobindo Pharma’s Atorvastatin Calcium Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), LIPITOR® Tablets manufactured […]

February 09, 2024


Aurobindo Receives FDA Approval for Deflazacort Tablets 6mg, 18mg, 30mg, & 36mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Deflazacort Tablets, 6mg, 18mg, 30mg, & 36mg. Aurobindo Pharma’s Deflazacort Tablets are an AB-rated generic equivalent to the reference listed drug (RLD), EMFLAZA® Tablets manufactured by PTC Therapeutics Inc.  Deflazacort Tablets are […]

January 24, 2024


Aurobindo Receives FDA Approval for Lacosamide Oral Solution USP, 10 mg/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 Lacosamide Oral Solution USP, 10 mg/mL. Aurobindo Pharma’s Lacosamide Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), VIMPAT® Oral Solution manufactured by UCB, Inc. Lacosamide Oral Solution […]

January 08, 2024


Aurobindo Receives FDA Approval for Enalapril Maleate Oral Solution, 1 mg/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 Enalapril Maleate Oral Solution, 1 mg/mL. Aurobindo Pharma’s Enalapril Maleate Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Epaned® Oral Solution manufactured by Azurity Pharmaceuticals, Inc. Enalapril […]

January 05, 2024


Aurobindo Receives FDA Approval for Mycophenolate Mofetil Capsules USP, 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 Mycophenolate Mofetil Capsules USP, 250 mg. Aurobindo Pharma’s Mycophenolate Mofetil Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), CellCept Capsules manufactured by Roche Palo Alto LLC. Mycophenolate Mofetil […]

December 14, 2023


Aurobindo Receives FDA Approval for Diazepam Tablets USP, 2 mg, 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 Diazepam Tablets USP, 2 mg, 5 mg and 10 mg. Aurobindo Pharma’s Diazepam Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Valium Tablets manufactured by Waylis Therapeutics LLC. […]

December 06, 2023


Aurobindo Receives FDA Approval for Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg. Aurobindo Pharma’s Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), are an AB-rated […]