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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022399
Company: AZURITY

Medication Guide

Summary Review

Products on NDA 022399

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HORIZANT	GABAPENTIN ENACARBIL	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
HORIZANT	GABAPENTIN ENACARBIL	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022399

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022399s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022399Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022399Orig1s011ltr.pdf
04/17/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022399Orig1s010ltr.pdf
10/29/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/01/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s008ltr.pdf
12/26/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf
12/26/2012	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399Orig1s006,007ltr.pdf
03/27/2013	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022399Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022399Orig1s005.pdf
04/18/2012	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s004ltr.pdf
06/06/2012	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022399s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022399Orig1s003.pdf

Labels for NDA 022399

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s010lbl.pdf
04/02/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s011lbl.pdf
05/01/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s008lbl.pdf
03/27/2013	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022399s005lbl.pdf
12/26/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf
12/26/2012	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s006,s007lbl.pdf
06/06/2012	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s003lbl.pdf
04/18/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022399s004lbl.pdf
04/06/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdf

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