APPLICATION
ANDA091076
TYPE
ANDA
ORIGINAL APPROVAL
2023-05-30
LATEST ACTION
2024-12-17
ROUTE
RECTAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
DIAZEPAMPrescription
DIAZEPAM 10MG/2ML (5MG/ML) · GEL · RECTAL
DIAZEPAMPrescription
DIAZEPAM 20MG/4ML (5MG/ML) · GEL · RECTAL
Approval history
2024-12-17Labeling · Supplement 2 · 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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