← FDA Drug Approvals (Drugs@FDA)
INDOMETHACIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2025-02-24
Drug application
- FDA Application #
ANDA215399- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- INDOMETHACIN
- Generic name
- INDOMETHACIN
- Active ingredients
- INDOMETHACIN
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Marketing status
- Prescription
- Sponsor
- AMNEAL
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2025-02-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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