APPLICATION
ANDA074830
TYPE
ANDA
ORIGINAL APPROVAL
1999-01-25
LATEST ACTION
2021-08-18
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription
Products
DESMOPRESSIN ACETATEPrescription
DESMOPRESSIN ACETATE 0.01MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2021-08-18Labeling · Supplement 22 · standardAP
2021-08-18Labeling · Supplement 23 · standardAP
2015-04-02Labeling · Supplement 15 · standardAP
2015-01-14Manufacturing (CMC) · Supplement 17 · unknownAP
2008-04-25Labeling · Supplement 13AP
2004-09-21Labeling · Supplement 8AP
2000-04-28Manufacturing (CMC) · Supplement 2AP
1999-10-25Labeling · Supplement 4AP
1999-09-13Manufacturing (CMC) · Supplement 1AP
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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