Treats infection caused by various strains of influenza A virus. ANDA 208278, held by Zydus Pharms. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 208278 (Amantadine Hydrochloride), held by Zydus Pharms, was first approved by FDA on May 31, 2016, with 2 approved supplements 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 |
|---|---|---|---|
| May 31, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride100MG · capsule;oral | Amantadine Hydrochloride | Rx |
| Jul 10, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 20, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 31, 2016 | 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
