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 …
Alembic Pharma Gets USFDA Approval for Paroxetine ER Tablets Kumar Jeetendra | March 30, 2026 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Paroxetine Extended-Release Tablets USP, 12.5 mg. The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Tablets, 12.5 mg, of Apotex Inc. …
Alembic Pharma Wins USFDA Approval for Dapagliflozin Tablets Kumar Jeetendra | April 7, 2026 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. Alembic Pharmaceuticals Limited Gets USFDA Approval for Dapagliflozin Tablets The approved ANDA is therapeutically equivalent to the reference listed drug product …
