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FDA NDA · NDA011707

OPANA

Sponsor: ENDO PHARMS

APPLICATION
NDA011707
TYPE
NDA
ORIGINAL APPROVAL
1959-04-02
LATEST ACTION
2019-10-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OPANA · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
OPANADiscontinued
OXYMORPHONE HYDROCHLORIDE 1.5MG/ML · INJECTABLE · INJECTION

Approval history

2019-10-07Labeling · Supplement 37 · standard — Label ↗AP
2016-12-16Labeling · Supplement 36 · standard — Letter ↗AP
2006-10-16Labeling · Supplement 31 · standard — Label ↗AP
2002-10-25Manufacturing (CMC) · Supplement 29 · standardAP
2002-04-16Manufacturing (CMC) · Supplement 27 · standardAP
2002-01-15Manufacturing (CMC) · Supplement 28 · standardAP
2000-09-25Manufacturing (CMC) · Supplement 24 · standardAP
1997-10-29Labeling · Supplement 26 · standardAP
1997-08-06Manufacturing (CMC) · Supplement 25 · standardAP
1996-10-15Labeling · Supplement 23 · standardAP
1994-08-11Manufacturing (CMC) · Supplement 22 · standardAP
1994-05-11Manufacturing (CMC) · Supplement 21 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 17 · standardAP
1987-12-08Manufacturing (CMC) · Supplement 20 · standardAP
1983-08-31Manufacturing (CMC) · Supplement 15 · standardAP
1983-08-31Manufacturing (CMC) · Supplement 16 · standardAP
1981-11-09Manufacturing (CMC) · Supplement 13 · standardAP
1981-04-01Manufacturing (CMC) · Supplement 11 · standardAP
1976-03-26Labeling · Supplement 8AP
1959-04-02Type 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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