← FDA Drug Approvals (Drugs@FDA)
VARENICLINE TARTRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2024-10-29
Drug application
- FDA Application #
ANDA219106- 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
- REGCON HOLDINGS
- Manufacturer
- Indoco Remedies Limited
- First approval
- 2024-10-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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