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Results For "New-Drug-Application"

372 News Found

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
News | February 24, 2021

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.


Granules India announces approval of Potassium Chloride ER Capsules
News | February 18, 2021

Granules India announces approval of Potassium Chloride ER Capsules

Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).