← FDA Drug Approvals (Drugs@FDA)
VARENICLINE TARTRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2025-05-02
Drug application
- FDA Application #
ANDA214595- 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
- AUROBINDO PHARMA
- Manufacturer
- Aurobindo Pharma Limited
- First approval
- 2025-05-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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