# VARENICLINE TARTRATE
> **ANDA213019** · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2024-03-19
## Drug
- **FDA Application Number:** ANDA213019
- **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:** AJANTA PHARMA LTD
- **Manufacturer:** Ajanta Pharma USA Inc.
- **First approval:** 2024-03-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213019)
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