Treats infection caused by various strains of influenza A virus. ANDA 214284, held by Alembic. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 214284 (Amantadine Hydrochloride), held by Alembic, was first approved by FDA on Oct 15, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE 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. Influenza A Prophylaxis Amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride100MG · tablet;oral | Amantadine Hydrochloride | Rx |
| Jul 10, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 15, 2020 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
