← FDA Drug Approvals (Drugs@FDA)
MIPLYFFA
NDA · New Drug Application · Sponsor: ZEVRA DENMARK · Approved 2024-09-20
Drug application
- FDA Application #
NDA214927
- Application type
- New Drug Application
- Brand name
- MIPLYFFA
- Generic name
- ARIMOCLOMOL CITRATE
- Active ingredients
- ARIMOCLOMOL CITRATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ZEVRA DENMARK
- Manufacturer
- Acer Therapeutics Inc.
- First approval
- 2024-09-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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