An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021526
Company: MENARINI INTL

Products on NDA 021526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RANEXA	RANOLAZINE	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
RANEXA	RANOLAZINE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021526

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.html

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-Package Insert, 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.html
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

Labels for NDA 021526

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021526s014lbl.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

Top