APPLICATION
ANDA076703
TYPE
ANDA
ORIGINAL APPROVAL
2005-01-27
LATEST ACTION
2019-10-24
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription
Products
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)Prescription
DESMOPRESSIN ACETATE 0.01MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-10-24Labeling · Supplement 27 · standardAP
2019-10-24Labeling · Supplement 31 · standardAP
2009-08-20Labeling · Supplement 17AP
2008-03-11Labeling · Supplement 14AP
2007-05-23Labeling · Supplement 10AP
2006-12-03Labeling · Supplement 9AP
2006-03-02Labeling · Supplement 2AP
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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