← FDA DRUG APPROVALS

FDA NDA · NDA206544

MORPHABOND ER

Sponsor: OHEMO LIFE

APPLICATION
NDA206544
TYPE
NDA
ORIGINAL APPROVAL
2015-10-02
LATEST ACTION
2019-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MORPHABOND ER · ReferenceDiscontinued
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL
MORPHABOND ER · ReferenceDiscontinued
MORPHINE SULFATE 15MG · TABLET, EXTENDED RELEASE · ORAL
MORPHABOND ER · ReferenceDiscontinued
MORPHINE SULFATE 100MG · TABLET, EXTENDED RELEASE · ORAL
MORPHABOND ER · ReferenceDiscontinued
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-10-07Labeling · Supplement 12 · standard — Letter ↗AP
2018-12-31Labeling · Supplement 9 · standard — Label ↗AP
2018-09-18Labeling · Supplement 10 · standard — Label ↗AP
2018-09-18REMS · Supplement 8 — Label ↗AP
2018-06-01Labeling · Supplement 7 · standard — Label ↗AP
2017-05-26REMS · Supplement 6 — Letter ↗AP
2016-12-16Labeling · Supplement 2 · standard — Label ↗AP
2016-12-16Labeling · Supplement 5 · standard — Label ↗AP
2016-09-30REMS · Supplement 4 — Letter ↗AP
2016-04-20REMS · Supplement 1 — Letter ↗AP
2015-10-02Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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