← FDA Drug Approvals (Drugs@FDA)
AMANTADINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HUMANWELL PURACAP · Approved 2022-12-20
Drug application
- FDA Application #
ANDA214580- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AMANTADINE HYDROCHLORIDE
- Generic name
- AMANTADINE HYDROCHLORIDE
- Active ingredients
- AMANTADINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HUMANWELL PURACAP
- Manufacturer
- EPIC PHARMA LLC
- First approval
- 2022-12-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown