Treats infection caused by various strains of influenza A virus. ANDA 214178, held by Pharmobedient. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 214178 (Amantadine Hydrochloride), held by Pharmobedient, was first approved by FDA on Aug 20, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Amantadine Hydrochloride Oral Solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Oral Solution USP is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine Hydrochloride Oral Solution USP is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride50MG/5ML · syrup;oral | Amantadine Hydrochloride | Rx |
| Dec 5, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 20, 2021 | 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
