APPLICATION
ANDA210223
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-17
LATEST ACTION
2025-08-27
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DESMOPRESSIN ACETATEPrescription
DESMOPRESSIN ACETATE 0.004MG/ML · INJECTABLE · INJECTION
Approval history
2025-08-27Manufacturing (CMC) · Supplement 5 · unknownAP
2020-09-17UNKNOWN · Original · 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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