Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022527
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GILENYA | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| GILENYA | FINGOLIMOD HYDROCHLORIDE | EQ 0.25MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/21/2010 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022527s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022527s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022527Orig1s000sumr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-39 | Manufacturing (CMC)-Control |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022527Orig1s039lbl.pdf | |
| 08/10/2023 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022527s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022527Orig1s038ltr.pdf | |
| 12/26/2019 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022527Orig1s031ltr.pdf | |
| 08/16/2019 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022527Orig1s029, 022527Orig1s030ltr.pdf | |
| 08/16/2019 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022527Orig1s029,%20022527Orig1s030ltr.pdf | |
| 10/26/2018 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s027lbl.pdf | |
| 01/11/2019 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022527Orig1s026ltr.pdf | |
| 05/11/2018 | SUPPL-24 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022527Orig1s024ltr.pdf | |
| 12/15/2017 | SUPPL-22 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022527s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/22527Orig1s022ltr.pdf | |
| 11/29/2016 | SUPPL-21 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s021ltr.pdf |
| 08/04/2015 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s019ltr.pdf | |
| 02/19/2016 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022527Orig1s018ltr.pdf | |
| 07/02/2015 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s016ltr.pdf | |
| 05/14/2015 | SUPPL-15 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s015ltr.pdf |
| 08/22/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022527Orig1s013ltr.pdf | |
| 05/28/2013 | SUPPL-10 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022527Orig1s010ltr.pdf |
| 04/30/2014 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022527s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022527Orig1s009ltr.pdf | |
| 05/09/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s008ltr.pdf | |
| 03/18/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s006ltr.pdf | |
| 03/01/2012 | SUPPL-5 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022527s005ltr.pdf |
| 07/01/2011 | SUPPL-3 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s003lbl.pdf | |
| 07/20/2011 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022527s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-39 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022527Orig1s039lbl.pdf |
| 08/10/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022527s038lbl.pdf | |
| 12/26/2019 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s031lbl.pdf | |
| 08/16/2019 | SUPPL-30 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf | |
| 08/16/2019 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf | |
| 08/16/2019 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf | |
| 08/16/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf | |
| 01/11/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s26lbl.pdf | |
| 10/26/2018 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s027lbl.pdf | |
| 05/11/2018 | SUPPL-24 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s024lbl.pdf | |
| 12/15/2017 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022527s022lbl.pdf | |
| 02/19/2016 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf | |
| 02/19/2016 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022527s018lbl.pdf | |
| 08/04/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s019lbl.pdf | |
| 07/02/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s016lbl.pdf | |
| 05/01/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022527s013lbl.pdf | |
| 04/30/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022527s009lbl.pdf | |
| 05/09/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf | |
| 03/18/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s006lbl.pdf | |
| 07/20/2011 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf | |
| 07/01/2011 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s003lbl.pdf | |
| 09/21/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022527s000lbl.pdf |
GILENYA
CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207991 | ACCORD HLTHCARE |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208004 | ALKEM LABS LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207993 | APOTEX |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207983 | AUROBINDO PHARMA LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207979 | BIOCON LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210252 | BIONPHARMA |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208000 | DR REDDYS |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207945 | EZRA VENTURES |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207985 | GLENMARK PHARMS LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207939 | HEC PHARM CO LTD |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207933 | HETERO LABS LTD V |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208005 | MYLAN |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208003 | PRINSTON INC |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208014 | SUN PHARM |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208008 | TEVA PHARMS USA |
| FINGOLIMOD HYDROCHLORIDE | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207994 | ZYDUS PHARMS |
| GILENYA | FINGOLIMOD HYDROCHLORIDE | EQ 0.5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022527 | NOVARTIS |
CAPSULE;ORAL; EQ 0.25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GILENYA | FINGOLIMOD HYDROCHLORIDE | EQ 0.25MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022527 | NOVARTIS |