Treats infection caused by various strains of influenza A virus. ANDA 212044, held by Rubicon Research. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 212044 (Amantadine Hydrochloride), held by Rubicon Research, was first approved by FDA on May 21, 2020, 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 |
|---|---|---|---|
| May 21, 2020 | 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 |
| May 21, 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
