Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021260
Company: KING PHARMS LLC
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 |