From USFDA
Alembic Pharmaceutical has received tentative approval from the USFDA for its Abbreviated New Drug Application for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boerhringer Ingelheim.Powered by Capital Market - Live News
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