← FDA Drug Approvals (Drugs@FDA)
INDOCIN
NDA · New Drug Application · Sponsor: ZYLA · Approved 1985-10-10
Drug application
- FDA Application #
NDA018332- Application type
- New Drug Application
- Brand name
- INDOCIN
- Generic name
- INDOMETHACIN
- Active ingredients
- INDOMETHACIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ZYLA
- Manufacturer
- Zyla Life Sciences US LLC
- First approval
- 1985-10-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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