Alembic Pharma gets USFDA endorsement for anti-depressant drug Kumar Jeetendra | July 8, 2021 Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Desipramine Hydrochloride tablets used in the treatment of depression. The approved product is therapeutically equivalent to the reference listed drug product Norpramin tablets of Validus Pharmaceuticals LLC. The company has received approval from the US Food and Drug …
Alembic Pharmaceuticals receives USFDA Tentative Approval for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. Kumar Jeetendra | January 7, 2022 7th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug …
Alembic Pharma Gets USFDA Approval for Divalproex Sodium Capsules, 125 mg Kumar Jeetendra | December 20, 2024 Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc. Alembic …