← FDA Drug Approvals (Drugs@FDA)
IVACAFTOR
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LTD · Approved 2025-01-08
Drug application
- FDA Application #
ANDA217431- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IVACAFTOR
- Generic name
- Ivacaftor
- Active ingredients
- IVACAFTOR
- Dosage form
- GRANULE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- LUPIN LTD
- First approval
- 2025-01-08
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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