# VARENICLINE TARTRATE
> **ANDA219106** · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2024-10-29
## Drug
- **FDA Application Number:** ANDA219106
- **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:** REGCON HOLDINGS
- **Manufacturer:** Indoco Remedies Limited
- **First approval:** 2024-10-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219106)
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