# ANDA219416
> **ANDA219416** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABORATORIES LIMITED · Approved 2025-11-04
## Drug
- **FDA Application Number:** ANDA219416
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** —
- **Generic name:** —
- **Active ingredients:** —
- **Dosage form:** —
- **Route:** —
- **Marketing status:** —
- **Sponsor:** ALKEM LABORATORIES LIMITED
- **First approval:** 2025-11-04
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219416)
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*MORVS · CC0 1.0*