Treats infection caused by various strains of influenza A virus. ANDA 214580, held by Humanwell Puracap. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 214580 (Amantadine Hydrochloride), held by Humanwell Puracap, was first approved by FDA on Dec 20, 2022, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride100MG · capsule;oral | Amantadine Hydrochloride | Rx |
| Jul 10, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 20, 2022 | 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
