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FDA NDA · NDA012945

DIAMOX

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA012945
TYPE
NDA
ORIGINAL APPROVAL
1962-01-25
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DIAMOX · ReferenceDiscontinued
ACETAZOLAMIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-09-20Labeling · Supplement 48 · standard — Label ↗AP
2022-05-13Labeling · Supplement 47 · standard — Letter ↗AP
2014-04-09Manufacturing (CMC) · Supplement 46AP
2014-03-19Manufacturing (CMC) · Supplement 45AP
2005-03-15Manufacturing (CMC) · Supplement 37 — Label ↗AP
2005-03-15Labeling · Supplement 38 · standard — Letter ↗AP
2003-07-21Labeling · Supplement 34 · standardAP
1999-09-27Manufacturing (CMC) · Supplement 30AP
1995-04-25Manufacturing (CMC) · Supplement 28AP
1962-01-25Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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