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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021260
Company: KING PHARMS LLC

Medication Guide

REMS

Products on NDA 021260

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVINZA	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
AVINZA	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
AVINZA	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
AVINZA	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
AVINZA	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
AVINZA	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21260lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21260ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-260_Avinza.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2015	SUPPL-24		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021260Orig1s024ltr.pdf
08/19/2014	SUPPL-23		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021260Orig1s023ltr.pdf
04/16/2014	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021260s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021260Orig1s022ltr.pdf
04/15/2013	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021260Orig1s018ltr.pdf
05/06/2013	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021260s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021260Orig1s017ltr.pdf
07/09/2012	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021260Orig1s016ltr.pdf
07/09/2012	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021260s015ltr.pdf
12/18/2008	SUPPL-13	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021260s013ltr.pdf
10/18/2005	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021260s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021260s006ltr.pdf
11/08/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021260

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2014	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021260s022lbl.pdf
05/06/2013	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021260s017lbl.pdf
07/09/2012	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s016lbl.pdf
07/09/2012	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021260s015lbl.pdf
10/18/2005	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021260s006lbl.pdf
03/20/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21260lbl.pdf

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