← FDA Drug Approvals (Drugs@FDA)
VARENICLINE TARTRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UMEDICA · Approved 2026-01-09
Drug application
- FDA Application #
ANDA218985- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- VARENICLINE TARTRATE
- Generic name
- VARENICLINE
- Active ingredients
- VARENICLINE TARTRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- UMEDICA
- Manufacturer
- Umedica Laboratories USA Inc.
- First approval
- 2026-01-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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