APPLICATION
NDA011738
TYPE
NDA
ORIGINAL APPROVAL
1960-05-31
LATEST ACTION
2000-09-25
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
NUMORPHANDiscontinued
OXYMORPHONE HYDROCHLORIDE 5MG · SUPPOSITORY · RECTAL
Approval history
2000-09-25Manufacturing (CMC) · Supplement 12 · standardAP
1997-10-29Labeling · Supplement 13 · standardAP
1996-10-15Labeling · Supplement 11 · standardAP
1994-05-11Manufacturing (CMC) · Supplement 10 · standardAP
1981-11-04Manufacturing (CMC) · Supplement 7 · standardAP
1960-05-31Type 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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