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Results For "U.S.-FDA"

246 News Found

Glenmark receives ANDA tentative approval for Nintedanib Capsules
News | June 26, 2021

Glenmark receives ANDA tentative approval for Nintedanib Capsules

According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion


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 Pharmaceuticals launches Rufinamide Tablets USP, 200 mg and 400 mg
News | June 02, 2021

Glenmark Pharmaceuticals launches Rufinamide Tablets USP, 200 mg and 400 mg

The Banzel Tablets, 200 mg and 400 mg market2 achieved annual sales of approximately $285.3 million.


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


Lupin launches penicillamine tablets USP
News | March 04, 2021

Lupin launches penicillamine tablets USP

Penicillamine Tablets USP, 250 mg (RLD: Depen) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT December 2020).


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.