← FDA DRUG APPROVALS

FDA NDA · NDA021260

AVINZA

Sponsor: KING PHARMS LLC

APPLICATION
NDA021260
TYPE
NDA
ORIGINAL APPROVAL
2002-03-20
LATEST ACTION
2015-06-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

AVINZADiscontinued
MORPHINE SULFATE 45MG · CAPSULE, EXTENDED RELEASE · ORAL
AVINZADiscontinued
MORPHINE SULFATE 90MG · CAPSULE, EXTENDED RELEASE · ORAL
AVINZADiscontinued
MORPHINE SULFATE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
AVINZADiscontinued
MORPHINE SULFATE 75MG · CAPSULE, EXTENDED RELEASE · ORAL
AVINZADiscontinued
MORPHINE SULFATE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
AVINZADiscontinued
MORPHINE SULFATE 60MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2015-06-26Supplement · Supplement 24 · standard — Letter ↗AP
2014-08-19Supplement · Supplement 23 · standard — Letter ↗AP
2014-04-16Labeling · Supplement 22 · standard — Letter ↗AP
2013-05-06Labeling · Supplement 17 · standard — Label ↗AP
2013-04-15Labeling · Supplement 18 · standard — Letter ↗AP
2012-07-09Labeling · Supplement 16 · standard — Letter ↗AP
2012-07-09Labeling · Supplement 15 · standard — Label ↗AP
2008-12-18Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2005-10-18Labeling · Supplement 6 · standard — Letter ↗AP
2002-11-08Manufacturing (CMC) · Supplement 2 · standardAP
2002-03-20Type 3 - New Dosage Form · Original · standard — Review ↗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.

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