# VARENICLINE TARTRATE
> **ANDA218302** · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS · Approved 2025-10-29
## Drug
- **FDA Application Number:** ANDA218302
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** VARENICLINE TARTRATE
- **Generic name:** VARENICLINE TARTRATE
- **Active ingredients:** VARENICLINE TARTRATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** MICRO LABS
- **Manufacturer:** Micro Labs Limited
- **First approval:** 2025-10-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218302)
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