Treats infection caused by various strains of influenza A virus. ANDA 75060, held by Pharmobedient. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 75060 (Amantadine Hydrochloride), held by Pharmobedient, was first approved by FDA on Dec 24, 1998, with 6 approved supplements 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 is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis: Amantadine hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 24, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride50MG/5ML · syrup;oral | Amantadine Hydrochloride | Rx |
| Jul 10, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 24, 2024 | Supplement 12Manufacturing | Approved | None posted |
| Aug 31, 2011 | Supplement 5Labeling | Approved | None posted |
| Sep 14, 2007 | Supplement 3Labeling | Approved | None posted |
| Jan 12, 2007 | Supplement 2Labeling | Approved | None posted |
| Aug 15, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Dec 24, 1998 | Original application | Approved |
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
