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FDA NDA · NDA019977

ORAMORPH SR

Sponsor: XANODYNE PHARMS INC

APPLICATION
NDA019977
TYPE
NDA
ORIGINAL APPROVAL
1991-08-15
LATEST ACTION
2001-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ORAMORPH SRDiscontinued
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
ORAMORPH SRDiscontinued
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL
ORAMORPH SRDiscontinued
MORPHINE SULFATE 15MG · TABLET, EXTENDED RELEASE · ORAL
ORAMORPH SRDiscontinued
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2001-07-13Labeling · Supplement 4 · standard — Letter ↗AP
2001-07-13Labeling · Supplement 7 · standard — Letter ↗AP
1994-11-23Manufacturing (CMC) · Supplement 5 · standardAP
1994-04-18Manufacturing (CMC) · Supplement 2 · standardAP
1994-03-11Manufacturing (CMC) · Supplement 3 · standardAP
1991-08-15Type 5 - New Formulation or New Manufacturer · 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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