Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022030
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOVIAZ FESOTERODINE FUMARATE 4MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
TOVIAZ FESOTERODINE FUMARATE 8MG TABLET, 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
10/31/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022030s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022030s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022030s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2017 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/23/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/13/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/01/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022030s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022030Orig1s009ltr.pdf
12/30/2011 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s008ltr.pdf
02/10/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s007ltr.pdf
11/01/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022030s006ltr.pdf
04/02/2010 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022030s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022030s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022030s009lbl.pdf
12/30/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s008lbl.pdf
11/01/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s006lbl.pdf
02/10/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022030s007lbl.pdf
04/02/2010 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022030s004lbl.pdf
10/31/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022030lbl.pdf

TOVIAZ

TABLET, EXTENDED RELEASE;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FESOTERODINE FUMARATE FESOTERODINE FUMARATE 4MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205007 AUROBINDO PHARMA LTD
TOVIAZ FESOTERODINE FUMARATE 4MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022030 PFIZER

TABLET, EXTENDED RELEASE;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FESOTERODINE FUMARATE FESOTERODINE FUMARATE 8MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205007 AUROBINDO PHARMA LTD
TOVIAZ FESOTERODINE FUMARATE 8MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022030 PFIZER

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