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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205002
Company: AMNEAL PHARMS NY

Products on ANDA 205002

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205002

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/04/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2024	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205002

FESOTERODINE FUMARATE

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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