APPLICATION
ANDA211862
TYPE
ANDA
ORIGINAL APPROVAL
2023-12-04
LATEST ACTION
2025-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VARENICLINE TARTRATEPrescription
VARENICLINE TARTRATE EQ 1MG BASE · TABLET · ORAL
VARENICLINE TARTRATEPrescription
VARENICLINE TARTRATE EQ 0.5MG BASE · TABLET · ORAL
Approval history
2025-12-18Labeling · Supplement 4 · standardAP
2023-12-04UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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