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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213397
Company: AJANTA PHARMA LTD

Products on ANDA 213397

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213397

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213397

TOLTERODINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DETROL LA	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021228	UPJOHN
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213397	AJANTA PHARMA LTD
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213858	AMTA
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206419	HETERO LABS LTD III
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	204562	INVENTIA HLTHCARE
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	079141	TEVA PHARMS USA
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203016	TORRENT

CAPSULE, EXTENDED RELEASE;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DETROL LA	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021228	UPJOHN
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213397	AJANTA PHARMA LTD
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213858	AMTA
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206419	HETERO LABS LTD III
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	204562	INVENTIA HLTHCARE
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	079141	TEVA PHARMS USA
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203016	TORRENT

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