APPLICATION
NDA018938
TYPE
NDA
ORIGINAL APPROVAL
1984-03-30
LATEST ACTION
2022-07-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
DDAVP · ReferencePrescription
DESMOPRESSIN ACETATE 0.004MG/ML · INJECTABLE · INJECTION
DDAVPDiscontinued
DESMOPRESSIN ACETATE 0.015MG/ML · INJECTABLE · INJECTION
Approval history
2018-03-22Labeling · Supplement 35 · standardAP
2015-11-05Labeling · Supplement 29 · standardAP
2007-10-26Labeling · Supplement 27 · standardAP
2005-11-10Labeling · Supplement 23 · standardAP
2003-11-12Labeling · Supplement 19 · standardAP
2002-08-08Labeling · Supplement 17 · standardAP
1998-08-17Labeling · Supplement 13 · standardAP
1995-03-13Labeling · Supplement 10 · standardAP
1994-01-11Labeling · Supplement 9 · standardAP
1993-05-12Labeling · Supplement 8AP
1990-04-03Labeling · Supplement 5AP
1985-11-07Labeling · Supplement 2AP
1984-12-20Labeling · Supplement 1AP
1984-03-30Type 3 - New Dosage Form · Original · priorityAP
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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