# VARENICLINE TARTRATE
> **ANDA201785** · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2021-08-11
## Drug
- **FDA Application Number:** ANDA201785
- **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:** PH HEALTH
- **Manufacturer:** Par Health USA, LLC
- **First approval:** 2021-08-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201785)
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*MORVS · CC0 1.0*