Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022399
Company: AZURITY
Company: AZURITY
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 |
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 |
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 |