Alembic Pharmaceuticals receives USFDA approval for ANDA Amantadine Hydrochloride Tablets

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amantadine Hydrochloride Tablets, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Symmetrel Tablets, 100 mg, of Endo Pharmaceuticals, Inc. (Endo): Amantadine Hydrochloride Tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Tablets are also indicated in the treatment of parkinsonism and drug- . induced extrapyramidal reactions.

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