USFDA approves Alembic Pharmaceuticals’ Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe Kumar Jeetendra | December 26, 2022 26th December, 2022, Mumbai: 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), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), …
Alembic Pharmaceuticals announces USFDA Final Approval for Fluorouracil Injection USP Kumar Jeetendra | March 6, 2023 Alembic Pharmaceuticals Limited (Alembic) today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the Reference Listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 …
