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FDA NDA · NDA021795

DESMOPRESSIN ACETATE

Sponsor: FERRING

APPLICATION
NDA021795
TYPE
NDA
ORIGINAL APPROVAL
2008-05-08
LATEST ACTION
2019-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DESMOPRESSIN ACETATEDiscontinued
DESMOPRESSIN ACETATE 0.1MG · TABLET · ORAL
DESMOPRESSIN ACETATEDiscontinued
DESMOPRESSIN ACETATE 0.2MG · TABLET · ORAL

Approval history

2019-10-29Labeling · Supplement 6 · standard — Label ↗AP
2015-04-20Manufacturing (CMC) · Supplement 5 · standardAP
2013-02-28Manufacturing (CMC) · Supplement 3 · standardAP
2008-05-08Type 5 - New Formulation or New Manufacturer · Original · unknown — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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