FDA NDA · NDA017453
PROGLYCEM
Sponsor: TEVA BRANDED PHARM
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APPLICATION
NDA017453
TYPE
NDA
ORIGINAL APPROVAL
1976-05-28
LATEST ACTION
2026-10-06
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
PROGLYCEM · ReferencePrescription
DIAZOXIDE 50MG/ML · SUSPENSION · ORAL
Approval history
2016-05-13Manufacturing (CMC) · Supplement 21 · priorityAP
2013-11-21Manufacturing (CMC) · Supplement 16 · priorityAP
1989-07-28Labeling · Supplement 8AP
1987-05-14Manufacturing (CMC) · Supplement 7 · priorityAP
1987-02-24Manufacturing (CMC) · Supplement 6 · priorityAP
1984-12-04Manufacturing (CMC) · Supplement 5 · priorityAP
1982-12-14Labeling · Supplement 4AP
1981-06-23Manufacturing (CMC) · Supplement 3 · priorityAP
1980-07-09Manufacturing (CMC) · Supplement 2 · priorityAP
1979-09-07Labeling · Supplement 1AP
1976-05-28Type 3 - New Dosage Form · Original · priorityAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →