Drugs@FDA: FDA Approved Drug Products

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

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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