← FDA Drug Approvals (Drugs@FDA)
AMANTADINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS · Approved 2024-08-26
Drug application
- FDA Application #
ANDA214897- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AMANTADINE
- Generic name
- Amantadine
- Active ingredients
- AMANTADINE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- ZYDUS
- First approval
- 2024-08-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown