- The Alembic Pharmaceuticals has received approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride capsules, USP, 100 mg.
- The approved ANDA is therapeutically equivalent to the reference listed drug product Symmetrel capsules, 100mg, of Endo Pharmaceuticals, Inc.
- Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.
June 22, 2017
Stocks In News - USFDA
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