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FDA NDA · NDA009388

DIAMOX

Sponsor: TEVA WOMENS

APPLICATION
NDA009388
TYPE
NDA
ORIGINAL APPROVAL
1954-06-25
LATEST ACTION
2024-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DIAMOX · ReferenceDiscontinued
ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2024-09-20Labeling · Supplement 39 · standard — Label ↗AP
2022-05-13Labeling · Supplement 38 · standard — Letter ↗AP
2002-11-26Manufacturing (CMC) · Supplement 35 · standardAP
2000-09-06Manufacturing (CMC) · Supplement 32 · standardAP
1999-12-03Manufacturing (CMC) · Supplement 33 · standardAP
1994-07-01Labeling · Supplement 30 · standardAP
1994-07-01Manufacturing (CMC) · Supplement 31 · standardAP
1993-12-09Manufacturing (CMC) · Supplement 29 · standardAP
1990-12-13Manufacturing (CMC) · Supplement 28 · standardAP
1990-12-05Labeling · Supplement 25AP
1954-06-25Type 3 - New Dosage Form · Original · standardAP
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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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