← FDA Drug Approvals (Drugs@FDA)
AMANTADINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 1995-07-17
Drug application
- FDA Application #
ANDA074509- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AMANTADINE HYDROCHLORIDE
- Generic name
- AMANTADINE HYDROCHLORIDE
- Active ingredients
- AMANTADINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PHARM ASSOC
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- First approval
- 1995-07-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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