Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020771
Company: PHARMACIA AND UPJOHN
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
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.

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

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 PHARMACIA AND UPJOHN
TOLTERODINE TARTRATE TOLTERODINE TARTRATE 1MG TABLET;ORAL Prescription No AB 200164 APOTEX CORP
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 202641 MYLAN PHARMS INC

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 PHARMACIA AND UPJOHN
TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG TABLET;ORAL Prescription No AB 200164 APOTEX CORP
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 202641 MYLAN PHARMS INC

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