Treats infection caused by various strains of influenza A virus. ANDA 209047, held by Strides Pharma. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 209047 (Amantadine Hydrochloride), held by Strides Pharma, was first approved by FDA on Jun 7, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride100MG · capsule;oral | Amantadine Hydrochloride | Rx |
| Jul 10, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 7, 2017 | 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
