← FDA DRUG APPROVALS

FDA NDA · NDA021333

MINIRIN

Sponsor: FERRING

APPLICATION
NDA021333
TYPE
NDA
ORIGINAL APPROVAL
2002-09-16
LATEST ACTION
2018-05-29
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

MINIRIN · ReferenceDiscontinued
DESMOPRESSIN ACETATE 0.01MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2018-05-29Labeling · Supplement 10 · standard — Letter ↗AP
2013-11-08Labeling · Supplement 7 · standard — Letter ↗AP
2013-09-04Manufacturing (CMC) · Supplement 9 · standardAP
2013-01-11Manufacturing (CMC) · Supplement 8 · standardAP
2003-09-04Labeling · Supplement 1 · standard — Label ↗AP
2002-09-16Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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