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September 06, 2023


Aurobindo Receives FDA Approval for Loperamide Hydrochloride Capsules USP 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 Loperamide Hydrochloride Capsules USP, 2mg. Aurobindo Pharma’s Loperamide Hydrochloride Capsules are an AB-rated generic equivalent to the reference listed drug (RLD),  Imodium® Capsules, manufactured by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division. Loperamide Hydrochloride […]

August 18, 2023


Aurobindo Receives FDA Approval for Fluphenazine Hydrochloride Tablets 1mg, 2.5mg, 5mg, and 10mg 

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Fluphenazine Hydrochloride Tablets 1mg, 2.5mg, 5mg, and 10mg. Aurobindo Pharma’s Fluphenazine Hydrochloride Tablets are an AB-rated generic equivalent to the reference listed drug (RLD), Prolixin Tablets manufactured by Apothecon Inc. Fluphenazine Hydrochloride Tablets are indicated for : […]

July 31, 2023


Aurobindo Receives FDA Approval for Saxagliptin Tablets, 2.5mg and 5mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Saxagliptin Tablets. Aurobindo Pharma’s Saxagliptin Tablets are an are an AB-rated generic equivalent to the reference listed drug (RLD),Onglyza Tablets, manufactured by AstraZeneca AB. Saxagliptin Tablets, are indicated for : An adjunct […]

July 11, 2023


Aurobindo Receives FDA Approval for Ramelteon Tablets, 8 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 for Aurobindo Receives FDA Approval Ramelteon Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), ROZEREM® Tablets manufactured by Takeda Pharmaceuticals USA Inc. Ramelteon Tablets, are indicated for : Treatment of […]

June 26, 2023


Aurobindo Receives FDA Approval for Rufinamide Tablets USP, 200mg and 400mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Rufinamide Tablets USP, 200mg and 400mg. Aurobindo Pharma’s Rufinamide Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Banzel® Tablets, manufactured by Eisai Inc. Rufinamide Tablets, are indicated for: […]

May 22, 2023


Aurobindo Receives FDA Approval for Prednisolone Tablets USP, 5mg.

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Prednisolone Tablets USP, 5mg. Aurobindo Pharma’s Prednisolone Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Prednisolone (MillipredTM) Tablets USP, manufactured by Watson Laboratories Inc. Prednisolone Tablets, are indicated in the following […]

April 03, 2023


Aurobindo Receives FDA Approval for Prazosin Hydrochloride Capsules USP, 1mg, 2mg and 5mg.

Aurobindo Receives FDA Approval for Prednisolone Tablets USP, 5mg Aurobindo Receives FDA Approval for Prednisolone Tablets USP, 5mg East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Prazosin Hydrochloride Capsules USP, 1mg, 2mg and 5mg. Aurobindo Pharma’s Prazosin Hydrochloride Capsules, are an AB-rated generic equivalent to the reference listed […]

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 […]

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 […]

January 10, 2023


Aurobindo Receives FDA Approval for Emzahh (Norethindrone Tablets USP), 0.35mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Emzahh (Norethindrone Tablets USP), 0.35mg. Aurobindo Pharma’s Emzahh (Norethindrone Tablets USP), are an AB-rated generic equivalent to the reference listed drug (RLD), ORTHO MICRONOR® Tablets manufactured by Janssen Pharmaceuticals Inc.  Emzahh (Norethindrone Tablets USP) are indicated […]