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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201785
Company: PAR PHARM INC

Products on ANDA 201785

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201785

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2021	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201785Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2024	SUPPL-5	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201785

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	217283	AVALANCHE PHARM
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	217151	LEADING PHARMA
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	214255	MANKIND PHARMA
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	201785	PAR PHARM INC
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	217283	AVALANCHE PHARM
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	217151	LEADING PHARMA
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	214255	MANKIND PHARMA
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	201785	PAR PHARM INC
VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	216723	ZYDUS

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