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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091464
Company: TEVA PHARMS USA

Products on ANDA 091464

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	AB	No	No
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091464Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2022	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/20/2019	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091464

SOLIFENACIN SUCCINATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	205575	ALEMBIC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210224	ALKEM LABS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	215761	ANNORA PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	206817	AUROBINDO PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210281	BOSTAL
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210582	CHARTWELL RX
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	209239	GLENMARK SPECLT
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	205484	JUBILANT GENERICS
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	204374	MACLEODS PHARMS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	210688	MSN
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	212214	NOVITIUM PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	209333	QILU
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	211423	RISING
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	211657	SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	091464	TEVA PHARMS USA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	211701	UNICHEM
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	No	AB	202551	WATSON LABS INC
VESICARE	SOLIFENACIN SUCCINATE	5MG	TABLET;ORAL	Prescription	Yes	AB	021518	ASTELLAS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	205575	ALEMBIC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210224	ALKEM LABS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	215761	ANNORA PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	206817	AUROBINDO PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210281	BOSTAL
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210582	CHARTWELL RX
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	209239	GLENMARK SPECLT
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	205484	JUBILANT GENERICS
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	204374	MACLEODS PHARMS LTD
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	210688	MSN
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	212214	NOVITIUM PHARMA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	209333	QILU
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	211423	RISING
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	211657	SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	091464	TEVA PHARMS USA
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	211701	UNICHEM
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	No	AB	202551	WATSON LABS INC
VESICARE	SOLIFENACIN SUCCINATE	10MG	TABLET;ORAL	Prescription	Yes	AB	021518	ASTELLAS

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