← FDA DRUG APPROVALS
FDA ANDA · ANDA078271
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
Sponsor: SUN PHARM
APPLICATION
ANDA078271
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-23
LATEST ACTION
2019-10-24
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued
Products
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)Discontinued
DESMOPRESSIN ACETATE 0.01MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-10-24Labeling · Supplement 17 · standardAP
2013-12-23OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.