APPLICATION
NDA018749
TYPE
NDA
ORIGINAL APPROVAL
1983-05-31
LATEST ACTION
2015-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LITHOSTAT · ReferencePrescription
ACETOHYDROXAMIC ACID 250MG · TABLET · ORAL
Approval history
2015-01-26Manufacturing (CMC) · Supplement 9 · priorityAP
2000-05-19Manufacturing (CMC) · Supplement 7 · priorityAP
1988-08-03Labeling · Supplement 6AP
1986-08-06Manufacturing (CMC) · Supplement 4 · priorityAP
1984-11-05Manufacturing (CMC) · Supplement 2 · priorityAP
1984-01-11Manufacturing (CMC) · Supplement 3 · priorityAP
1983-11-18Labeling · Supplement 1AP
1983-05-31Type 1 - New Molecular Entity · Original · priorityAP
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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