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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204946
Company: ZYDUS PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/03/2017 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
02/27/2023 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/27/2023 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/27/2023 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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 204504 ANI PHARMS
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 204504 ANI PHARMS
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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