Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA® Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.
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source https://www.pharmatutor.org/pharma-news/2021/alembic-pharmaceuticals-announces-usfda-tentative-approval-for-dabiqatran-etexilate-capsules
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