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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022030
Company: PFIZER

Summary Review

Products on NDA 022030

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022030

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
02/28/2024	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022030s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022030Orig1s022,023ltr.pdf
02/28/2024	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022030s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022030Orig1s022,023ltr.pdf
06/17/2021	SUPPL-19	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022030s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022030Orig1s019ltr.pdf
11/12/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022030s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022030Orig1s014ltr.pdf
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

Labels for NDA 022030

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022030s022s023lbl.pdf
02/28/2024	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022030s022s023lbl.pdf
06/17/2021	SUPPL-19	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022030s019lbl.pdf
11/12/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022030s014lbl.pdf
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

Therapeutic Equivalents for NDA 022030

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	204973	ALEMBIC
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204827	ALKEM LABS LTD
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205002	AMNEAL PHARMS NY
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205007	AUROBINDO PHARMA
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204975	DR REDDYS
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204792	HETERO LABS LTD V
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204946	ZYDUS PHARMS
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	204973	ALEMBIC
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204827	ALKEM LABS LTD
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205002	AMNEAL PHARMS NY
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205007	AUROBINDO PHARMA
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204975	DR REDDYS
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204792	HETERO LABS LTD V
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204946	ZYDUS PHARMS
TOVIAZ	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022030	PFIZER

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