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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077006
Company: IVAX SUB TEVA PHARMS

Products on ANDA 077006

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	AB	No	No
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077006

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077006

TOLTERODINE TARTRATE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DETROL	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	Yes	AB	020771	UPJOHN
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	No	AB	204397	HETERO LABS LTD V
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	No	AB	077006	IVAX SUB TEVA PHARMS
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	No	AB	203409	MACLEODS PHARMS LTD
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	No	AB	210775	RISING
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	No	AB	205399	UNICHEM
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	1MG	TABLET;ORAL	Prescription	No	AB	204721	UNIQUE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DETROL	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	Yes	AB	020771	UPJOHN
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	204397	HETERO LABS LTD V
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	077006	IVAX SUB TEVA PHARMS
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	203409	MACLEODS PHARMS LTD
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	210775	RISING
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	205399	UNICHEM
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	204721	UNIQUE

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