Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021526
Company: MENARINI INTL
Company: MENARINI INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RANEXA | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
RANEXA | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
01/27/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021526s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021526s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/29/2019 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021526s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021526Orig1s035ltr.pdf | |
08/07/2019 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021526s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021526Orig1s034ltr.pdf | |
04/22/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/10/2015 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/06/2016 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021526s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021526Orig1s029ltr.pdf | |
12/15/2015 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021526s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021526Orig1s028ltr.pdf | |
01/17/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/19/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s026ltr.pdf | |
11/12/2013 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021526Orig1s025ltr.pdf | |
07/25/2012 | SUPPL-22 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021526s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021526Orig1s022ltr.pdf | |
12/21/2011 | SUPPL-18 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s018ltr.pdf | |
07/11/2011 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021526s014ltr.pdf | |
09/23/2010 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021526s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021526s012ltr.pdf | |
03/26/2009 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021526s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021526s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021526Orig1s007.pdf | |
11/05/2008 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021526s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021526s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021526Orig1s004TOC.cfm | |
12/17/2007 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021526s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021526s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/29/2019 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021526s035lbl.pdf | |
08/07/2019 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021526s034lbl.pdf | |
01/06/2016 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021526s029lbl.pdf | |
12/15/2015 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021526s028lbl.pdf | |
12/19/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s026lbl.pdf | |
11/12/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021526s025lbl.pdf | |
07/25/2012 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021526s022lbl.pdf | |
12/21/2011 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s018lbl.pdf | |
07/11/2011 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.pdf | |
09/23/2010 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021526s012lbl.pdf | |
03/26/2009 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021526s007lbl.pdf | |
11/05/2008 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021526s004lbl.pdf | |
12/17/2007 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021526s002lbl.pdf | |
01/27/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021526s000lbl.pdf |