# INDOMETHACIN
> **ANDA216184** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2023-08-02
## Drug
- **FDA Application Number:** ANDA216184
- **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:** ZYDUS LIFESCIENCES
- **Manufacturer:** Zydus Pharmaceuticals USA Inc.
- **First approval:** 2023-08-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216184)
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