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Results For "ANDA-approval"

201 News Found

Unichem Labs gets ANDA approval for schizophrenia medicine
Drug Approval | December 03, 2021

Unichem Labs gets ANDA approval for schizophrenia medicine

The product will be commercialized from Unichem's Ghaziabad plant


Biocon Pharma receives ANDA approval for Mycophenolic acid
Drug Approval | December 03, 2021

Biocon Pharma receives ANDA approval for Mycophenolic acid

This further adds to Biocon’s portfolio of vertically integrated complex drug products


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm


Glenmark receives ANDA approval for treatment of acne
Drug Approval | September 21, 2021

Glenmark receives ANDA approval for treatment of acne

Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%


Unichem Labs receive ANDA approval for Metformin Hydrochloride
News | August 13, 2021

Unichem Labs receive ANDA approval for Metformin Hydrochloride

It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Glenmark receives ANDA approval for inhalation solution
News | June 24, 2021

Glenmark receives ANDA approval for inhalation solution

Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina


Glenmark receives ANDA approval for theophylline extended-release tablets
News | June 07, 2021

Glenmark receives ANDA approval for theophylline extended-release tablets

Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets


Glenmark receives ANDA approval for Icatibant Injection
News | May 25, 2021

Glenmark receives ANDA approval for Icatibant Injection

This marks Glenmark's first synthetic decapeptide injectable approval


Unichem Laboratories receives ANDA approval for Apremilast Tablets
News | February 20, 2021

Unichem Laboratories receives ANDA approval for Apremilast Tablets

Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .


Glenmark receives ANDA approval for Clindamycin Phosphate Gel
News | February 12, 2021

Glenmark receives ANDA approval for Clindamycin Phosphate Gel

According to IQVIA sales data for the 12 month period ending December 2020, the Cleocin T Gel, 1% market achieved annual sales of approximately $73.8 million.