APPLICATION
ANDA217151
TYPE
ANDA
ORIGINAL APPROVAL
2023-07-25
LATEST ACTION
2023-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VARENICLINE TARTRATEPrescription
VARENICLINE TARTRATE EQ 0.5MG BASE · TABLET · ORAL
VARENICLINE TARTRATEPrescription
VARENICLINE TARTRATE EQ 1MG BASE · TABLET · ORAL
Approval history
2023-07-25UNKNOWN · 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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