APPLICATION
NDA017736
TYPE
NDA
ORIGINAL APPROVAL
1981-09-24
LATEST ACTION
1989-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PAXIPAMDiscontinued
HALAZEPAM 40MG · TABLET · ORAL
PAXIPAMDiscontinued
HALAZEPAM 20MG · TABLET · ORAL
Approval history
1989-04-04Manufacturing (CMC) · Supplement 10 · standardAP
1986-10-28Manufacturing (CMC) · Supplement 7 · standardAP
1984-09-04Manufacturing (CMC) · Supplement 6 · standardAP
1984-05-11Manufacturing (CMC) · Supplement 4 · standardAP
1982-01-06Labeling · Supplement 3 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 2 · standardAP
1981-09-24Type 1 - New Molecular Entity · 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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