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FDA ANDA · ANDA204827

FESOTERODINE FUMARATE

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA204827
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-10
LATEST ACTION
2015-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

FESOTERODINE FUMARATEPrescription
FESOTERODINE FUMARATE 8MG · TABLET, EXTENDED RELEASE · ORAL
FESOTERODINE FUMARATEPrescription
FESOTERODINE FUMARATE 4MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-12-10UNKNOWN · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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