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FDA NDA · NDA017425

PROGLYCEM

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA017425
TYPE
NDA
ORIGINAL APPROVAL
1976-05-28
LATEST ACTION
2022-12-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROGLYCEMDiscontinued
DIAZOXIDE 50MG · CAPSULE · ORAL
PROGLYCEMDiscontinued
DIAZOXIDE 100MG · CAPSULE · ORAL

Approval history

2022-12-22Labeling · Supplement 17 · standard — Letter ↗AP
2015-09-18Labeling · Supplement 16 · 901 required — Letter ↗AP
1997-01-17Manufacturing (CMC) · Supplement 15 · priorityAP
1996-01-24Manufacturing (CMC) · Supplement 14 · priorityAP
1994-06-30Manufacturing (CMC) · Supplement 13 · priorityAP
1989-07-28Labeling · Supplement 12AP
1988-09-06Manufacturing (CMC) · Supplement 10 · priorityAP
1987-05-14Manufacturing (CMC) · Supplement 8 · priorityAP
1986-11-20Manufacturing (CMC) · Supplement 7 · priorityAP
1985-06-28Manufacturing (CMC) · Supplement 6 · priorityAP
1983-05-02Manufacturing (CMC) · Supplement 5 · priorityAP
1982-12-14Labeling · Supplement 4AP
1980-07-09Manufacturing (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
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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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