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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020771
Company: UPJOHN

Products on NDA 020771

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020771

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/1998	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20771lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20771ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20771_Detrol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
08/01/2012	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020771s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020771Orig1s028ltr.pdf
09/20/2011	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020771s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020771s024ltr.pdf
04/08/2009	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020771s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020771s022ltr.pdf
09/11/2008	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020771s019,021228s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020771s019, 021228s012ltr.pdf
03/16/2007	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020771s017, 21228s010ltr.pdf
03/24/2006	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020771s014ltr.pdf
10/17/2005	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020771s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020771s013ltr.pdf
01/05/2004	SUPPL-11	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20771slr011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020771_s011_DELTROL 1 & 2 MG.pdf
07/21/2003	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20771slr010ltr.pdf
07/20/2001	SUPPL-9	Manufacturing (CMC)-Packaging	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020771_s009_DETROL.pdf
10/24/2000	SUPPL-6	Labeling		Label is not available on this site.
11/09/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/06/2001	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20771s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20771s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020771_S004_DetrolTOC2.cfm
05/26/2000	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/31/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020771

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2012	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020771s028lbl.pdf
09/20/2011	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020771s024lbl.pdf
04/08/2009	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020771s022lbl.pdf
09/11/2008	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020771s019,021228s012lbl.pdf
10/17/2005	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020771s013lbl.pdf
04/06/2001	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20771s4lbl.pdf
03/25/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20771lbl.pdf

Therapeutic Equivalents for NDA 020771

DETROL

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	210775	ELYSIUM
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	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	210775	ELYSIUM
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	205399	UNICHEM
TOLTERODINE TARTRATE	TOLTERODINE TARTRATE	2MG	TABLET;ORAL	Prescription	No	AB	204721	UNIQUE

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