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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021228
Company: UPJOHN

Products on NDA 021228

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21228lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21228ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-228_Detrol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/13/2018	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021228Orig1s023ltr.pdf
07/28/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
08/01/2012	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021228s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021228Orig1s021ltr.pdf
09/20/2011	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021228s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021228s016ltr.pdf
01/05/2010	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021228s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021228s015ltr.pdf
09/11/2008	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020771s019, 021228s012ltr.pdf
03/16/2007	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021228Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020771s017, 21228s010ltr.pdf
07/14/2005	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021228s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021228s008ltr.pdf
10/20/2005	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021228s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021228s007ltr.pdf
04/14/2004	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21228se8-006_detrol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21228se8-006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021228_S006_DetrolTOC.cfm
01/15/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21228slr005ltr.pdf
07/21/2003	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21228slr004ltr.pdf
12/17/2001	SUPPL-3	Manufacturing (CMC)	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021228_S003_DetrolTOC.cfm
09/21/2001	SUPPL-2	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021228_S002_DetrolTOC.cfm
04/27/2001	SUPPL-1	Labeling	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21228s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021228_S001_DetrolTOC.cfm

Labels for NDA 021228

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/13/2018	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf
08/01/2012	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021228s021lbl.pdf
09/20/2011	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021228s016lbl.pdf
01/05/2010	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021228s015lbl.pdf
03/16/2007	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021228Orig1s010lbl.pdf
10/20/2005	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021228s007lbl.pdf
07/14/2005	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021228s008lbl.pdf
04/14/2004	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21228se8-006_detrol_lbl.pdf
04/27/2001	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21228s1lbl.pdf
12/22/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21228lbl.pdf

Therapeutic Equivalents for NDA 021228

DETROL LA

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
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	216917	UNICHEM

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
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	4MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	216917	UNICHEM

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