Alembic Pharmaceuticals receives USFDA Tentative Approval for Rivaroxaban Tablets, 10 mg, 15 mg, and 20 mg.

Alembic Pharmaceuticals receives USFDA Tentative Approval for Rivaroxaban Tablets, 10 mg, 15 mg, and 20 mg.

 

 

Alembic Pharmaceuticals Limited today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Rivaroxaban Tablets, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen).

Alembic Pharmaceuticals announces USFDA Final Approval for Doxycycline Hyclate Tablets USP. 100 mg.

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