← FDA DRUG APPROVALS

FDA NDA · NDA020616

KADIAN

Sponsor: ALLERGAN

APPLICATION
NDA020616
TYPE
NDA
ORIGINAL APPROVAL
1996-07-03
LATEST ACTION
2021-03-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 130MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 150MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 70MG · CAPSULE, EXTENDED RELEASE · ORAL
KADIAN · ReferenceDiscontinued
MORPHINE SULFATE 50MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2021-03-04Labeling · Supplement 65 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 63 · standard — Label ↗AP
2018-09-18REMS · Supplement 61 — Letter ↗AP
2018-09-18Labeling · Supplement 62 · standard — Letter ↗AP
2017-05-26REMS · Supplement 60 — Letter ↗AP
2016-12-16Labeling · Supplement 57 · standard — Letter ↗AP
2016-09-30REMS · Supplement 58 — Letter ↗AP
2016-04-20REMS · Supplement 55 — Letter ↗AP
2015-06-26REMS · Supplement 54 — Letter ↗AP
2014-08-19REMS · Supplement 53 — Letter ↗AP
2014-04-16Labeling · Supplement 51 · 901 required — Letter ↗AP
2014-04-14Manufacturing (CMC) · Supplement 52 · standardAP
2013-04-15REMS · Supplement 47 — Letter ↗AP
2013-03-27Labeling · Supplement 48 · standard — Letter ↗AP
2013-01-14Manufacturing (CMC) · Supplement 46 · standardAP
2012-07-09REMS · Supplement 41 — Label ↗AP
2012-07-09Manufacturing (CMC) · Supplement 44 · standard — Label ↗AP
2012-07-09Labeling · Supplement 36 · standardAP
2008-01-31Manufacturing (CMC) · Supplement 28AP
2007-04-20Manufacturing (CMC) · Supplement 25 — Label ↗AP
2007-02-27Manufacturing (CMC) · Supplement 17 · standard — Label ↗AP
2007-02-27Labeling · Supplement 21 · standard — Review ↗AP
2006-10-27Manufacturing (CMC) · Supplement 22 — Letter ↗AP
2005-09-28Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP
2002-03-28Manufacturing (CMC) · Supplement 9 · standardAP
2001-12-21Manufacturing (CMC) · Supplement 7 · standardAP
2001-12-18Manufacturing (CMC) · Supplement 8 · standardAP
2001-03-09Manufacturing (CMC) · Supplement 4 · standardAP
2001-02-08Manufacturing (CMC) · Supplement 6 · standardAP
2000-02-28Manufacturing (CMC) · Supplement 5 · standardAP
1999-07-16Labeling · Supplement 3 · standardAP
1998-04-08Manufacturing (CMC) · Supplement 2 · standardAP
1997-07-29Labeling · Supplement 1 · standard — Review ↗AP
1996-07-03Type 3 - New Dosage Form · Original · standard — Other ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →