Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091513
Company: APOTEX

Products on ANDA 091513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2011	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
01/30/2013	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091513

TROSPIUM CHLORIDE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	091513	APOTEX
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	091575	GLENMARK PHARMS LTD
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	204945	HERITAGE PHARMS INC
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	091688	INVAGEN PHARMS
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	091573	PADAGIS US
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	215781	ZAMEER PHARMS