← FDA Drug Approvals (Drugs@FDA)
AMANTADINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ONESOURCE SPECIALTY · Approved 2022-02-18
Drug application
- FDA Application #
ANDA211354
- 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
- ONESOURCE SPECIALTY
- Manufacturer
- Strides Pharma Science Limited
- First approval
- 2022-02-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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