APPLICATION
ANDA074888
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-15
LATEST ACTION
2024-08-28
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DESMOPRESSIN ACETATEPrescription
DESMOPRESSIN ACETATE 0.004MG/ML · INJECTABLE · INJECTION
Approval history
2024-08-28Labeling · Supplement 30 · standardAP
2019-07-25Labeling · Supplement 26 · standardAP
2019-07-25Labeling · Supplement 27 · standardAP
2009-03-27Labeling · Supplement 9AP
2002-03-25Labeling · Supplement 2AP
1998-08-10Manufacturing (CMC) · Supplement 1AP
1997-10-15OriginalAP
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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