Treats infection caused by various strains of influenza A virus. ANDA 78720, held by Bionpharma. Amantadine Hydrochloride.
As of Nov 15, 2026, ANDA 78720 (Amantadine Hydrochloride), held by Bionpharma, was first approved by FDA on May 29, 2008, with 4 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 29, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amantadine Hydrochloride100MG · capsule;oral | Amantadine Hydrochloride | Rx |
| Jul 10, 2025 | Supplement 24Labeling · Standard review | Approved | None posted |
| Oct 30, 2017 | Supplement 13Manufacturing | Approved | None posted |
| Aug 1, 2011 | Supplement 8Labeling | Approved | None posted |
| Mar 25, 2009 | Supplement 1Labeling | Approved | None posted |
| May 29, 2008 | 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
