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FDA ANDA · ANDA205032

FESOTERODINE FUMARATE

Sponsor: SUN PHARM INDS INC

APPLICATION
ANDA205032
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

FESOTERODINE FUMARATENone (Tentative Approval)
FESOTERODINE FUMARATE 8MG · TABLET, EXTENDED RELEASE · ORAL
FESOTERODINE FUMARATENone (Tentative Approval)
FESOTERODINE FUMARATE 4MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-02-27UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

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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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