APPLICATION
NDA011721
TYPE
NDA
ORIGINAL APPROVAL
1959-01-26
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NEPTAZANE · ReferenceDiscontinued
METHAZOLAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
NEPTAZANE · ReferenceDiscontinued
METHAZOLAMIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2009-03-13Labeling · Supplement 18AP
2009-03-13Labeling · Supplement 12AP
1999-01-05Manufacturing (CMC) · Supplement 27 · standardAP
1992-11-12Manufacturing (CMC) · Supplement 26 · standardAP
1991-11-25Efficacy · Supplement 15AP
1991-11-25Manufacturing (CMC) · Supplement 16 · standardAP
1991-11-25Manufacturing (CMC) · Supplement 22 · standardAP
1991-11-25Labeling · Supplement 25AP
1988-03-04Labeling · Supplement 23AP
1959-01-26Type 3 - New Dosage Form · Original · standardAP
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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