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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201962
Company: APOTEX

Products on ANDA 201962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	AB	No	No
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2023	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 201962

VARENICLINE TARTRATE

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	213019	AJANTA PHARMA LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	214557	ALKEM LABS LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201962	APOTEX
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	215931	DR REDDYS
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201785	ENDO OPERATIONS
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	214571	HETERO LABS LTD III
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	219106	INDOCO
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	211862	LUPIN LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	215048	MACLEODS PHARMS LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	214255	MANKIND PHARMA
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	217151	MEDLEY PHARMS
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	202019	MYLAN
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	217283	NE RX PHARMA
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	217115	PIRAMAL
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	216723	ZYDUS

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	213019	AJANTA PHARMA LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	214557	ALKEM LABS LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201962	APOTEX
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	215931	DR REDDYS
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201785	ENDO OPERATIONS
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	214571	HETERO LABS LTD III
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	219106	INDOCO
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	211862	LUPIN LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	215048	MACLEODS PHARMS LTD
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	214255	MANKIND PHARMA
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	217151	MEDLEY PHARMS
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	202019	MYLAN
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	217283	NE RX PHARMA
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	217115	PIRAMAL
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	216723	ZYDUS

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