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FDA NDA · NDA022517

NOCDURNA

Sponsor: FERRING PHARMS INC

APPLICATION
NDA022517
TYPE
NDA
ORIGINAL APPROVAL
2018-06-21
LATEST ACTION
2018-06-21
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NOCDURNA · ReferenceDiscontinued
DESMOPRESSIN ACETATE 0.0553MG · TABLET · SUBLINGUAL
NOCDURNA · ReferenceDiscontinued
DESMOPRESSIN ACETATE 0.0277MG · TABLET · SUBLINGUAL

Approval history

2018-06-21Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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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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