Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021228
Company: PHARMACIA AND UPJOHN
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
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
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

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 PHARMACIA AND UPJOHN
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 201486 MYLAN
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

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 PHARMACIA AND UPJOHN
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 201486 MYLAN
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

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