← FDA Drug Approvals (Drugs@FDA)
VARENICLINE TARTRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2024-12-09
Drug application
- FDA Application #
ANDA215048- 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
- MACLEODS PHARMS LTD
- Manufacturer
- Macleods Pharmaceuticals Limited
- First approval
- 2024-12-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown