APPLICATION
ANDA204751
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-22
LATEST ACTION
2025-03-21
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DESMOPRESSIN ACETATEPrescription
DESMOPRESSIN ACETATE 0.004MG/ML · INJECTABLE · INJECTION
Approval history
2025-03-21Labeling · Supplement 8 · standardAP
2019-07-25Labeling · Supplement 1 · standardAP
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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