← FDA DRUG APPROVALS

FDA NDA · NDA022321

EMBEDA

Sponsor: ALPHARMA PHARMS

APPLICATION
NDA022321
TYPE
NDA
ORIGINAL APPROVAL
2009-08-13
LATEST ACTION
2019-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

EMBEDA · ReferenceDiscontinued
MORPHINE SULFATE 80MG, NALTREXONE HYDROCHLORIDE 3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
EMBEDA · ReferenceDiscontinued
MORPHINE SULFATE 50MG, NALTREXONE HYDROCHLORIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
EMBEDA · ReferenceDiscontinued
MORPHINE SULFATE 20MG, NALTREXONE HYDROCHLORIDE 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
EMBEDA · ReferenceDiscontinued
MORPHINE SULFATE 100MG, NALTREXONE HYDROCHLORIDE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
EMBEDA · ReferenceDiscontinued
MORPHINE SULFATE 60MG, NALTREXONE HYDROCHLORIDE 2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
EMBEDA · ReferenceDiscontinued
MORPHINE SULFATE 30MG, NALTREXONE HYDROCHLORIDE 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2019-10-07Labeling · Supplement 30 · standard — Letter ↗AP
2018-09-18Labeling · Supplement 29 · standard — Label ↗AP
2018-09-18REMS · Supplement 28 — Label ↗AP
2017-05-26REMS · Supplement 26 — Letter ↗AP
2016-12-16Labeling · Supplement 22 · standard — Letter ↗AP
2016-09-30REMS · Supplement 23 — Letter ↗AP
2016-04-20REMS · Supplement 21 — Letter ↗AP
2015-11-10Manufacturing (CMC) · Supplement 20 · priorityAP
2015-06-26REMS · Supplement 19 — Letter ↗AP
2014-10-17Efficacy · Supplement 16 · standard — FDA Press Release ↗AP
2014-08-19REMS · Supplement 18 — Letter ↗AP
2014-04-16Labeling · Supplement 17 · 901 required — Letter ↗AP
2014-01-22Manufacturing (CMC) · Supplement 15 · priorityAP
2013-11-01Manufacturing (CMC) · Supplement 13 · priority — Label ↗AP
2013-06-03Labeling · Supplement 12 · standard — Label ↗AP
2013-04-15REMS · Supplement 10 — Letter ↗AP
2013-01-17Manufacturing (CMC) · Supplement 8 · priorityAP
2012-07-09Labeling · Supplement 7 · standard — Label ↗AP
2009-08-13Type 4 - New Combination · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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