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FDA NDA · NDA017453

PROGLYCEM

diazoxide

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA017453
TYPE
NDA
ORIGINAL APPROVAL
1976-05-28
LATEST ACTION
2024-07-18
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

PROGLYCEM · ReferencePrescription
DIAZOXIDE 50MG/ML · SUSPENSION · ORAL

Approval history

2024-07-18Labeling · Supplement 24 · standard — Letter ↗AP
2022-12-22Labeling · Supplement 23 · standard — Letter ↗AP
2016-05-13Manufacturing (CMC) · Supplement 21 · priorityAP
2015-09-18Labeling · Supplement 20 · 901 required — Label ↗AP
2013-11-21Manufacturing (CMC) · Supplement 16 · priorityAP
2008-12-17Manufacturing (CMC) · Supplement 14 — Letter ↗AP
2004-01-21Manufacturing (CMC) · Supplement 10 · priority — Letter ↗AP
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
VIEW ON DRUGS@FDA ↗

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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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