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March 31, 2023


Aurobindo Receives FDA Approval for Mesalamine Extended-Release Capsules USP, 0.375 g

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Mesalamine Extended-Release Capsules USP, 0.375 g. Aurobindo Pharma’s Mesalamine Extended-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Apriso Extended-Release Capsules manufactured by Salix Pharmaceuticals, Inc. Mesalamine Extended-Release […]

March 30, 2023


Aurobindo Receives FDA Approval for Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 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 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) 100mg. Aurobindo Pharma’s Nitrofurantoin Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Macrobid® Capsules manufactured by Almatica Pharma, LLC.  Nitrofurantoin Capsules are indicated for: The treatment […]

March 30, 2023


Aurobindo Receives FDA Approval for Pregabalin Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 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 Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. Aurobindo Pharma’s Pregabalin Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Lyrica® Capsules manufactured […]

March 29, 2023


Aurobindo Receives FDA Approval for Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15mg and 30mg   

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg. Aurobindo Pharma’s Lansoprazole Delayed-Release Orally Disintegrating Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), PREVACID® SoluTabTM Delayed-Release Orally Disintegrating Tablets […]

March 20, 2023


Aurobindo Receives FDA Approval for Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 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 Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg. Aurobindo Pharma’s Clomipramine Hydrochloride Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Anafranil Capsules manufactured by SpecGx […]

March 17, 2023


Aurobindo Receives FDA Approval for Prednisolone Tablets USP, 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 Prednisolone Tablets USP, 5 mg. Aurobindo Pharma’s Prednisolone Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Prednisolone Tablets manufactured by Watson Laboratories Inc. Prednisolone Tablets are indicated in […]

March 15, 2023


Aurobindo Receives FDA Approval for Emtricitabine Capsules, 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 Emtricitabine Capsules, 200 mg. Aurobindo Pharma’s Emtricitabine Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Emtriva® (emtricitabine) Capsules manufactured by Gilead Sciences, Inc. Emtricitabine Capsules are indicated in: […]

March 10, 2023


Aurobindo Receives FDA Approval for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 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 Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Aurobindo Pharma’s Lurasidone Hydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), LATUDA® tablets […]

March 09, 2023


Aurobindo Receives FDA Approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg, 133 mg/200 mg, and 167 mg/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 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg. Aurobindo Pharma’s Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, are an AB-rated generic equivalent to the reference […]

February 21, 2023


Aurobindo Receives FDA Approval for Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 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 Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg. Aurobindo Pharma’s Propafenone Hydrochloride Extended-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), RYTHMOL SR® Capsules […]

February 07, 2023


Aurobindo Receives FDA Approval for Linaclotide Capsules, 145 mcg and 290 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 Linaclotide Capsules, 145 mcg and 290 mcg. Aurobindo Pharma’s Linaclotide Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), LINZESS® (linaclotide) Capsules manufactured by Allergan Sales, LLC. Linaclotide Capsules […]

February 03, 2023


Aurobindo Receives FDA Approval for Diclofenac Sodium Topical Solution USP, 2% w/w

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Diclofenac Sodium Topical Solution USP, 2% w/w. Aurobindo Pharma’s Diclofenac Sodium Topical Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Pennsaid® Topical Solution manufactured by Horizon Therapeutics. Diclofenac Sodium Topical Solution are indicated for […]