Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022287
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXILANT | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| DEXILANT | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/30/2009 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022287s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022287s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022287s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022287Orig1s038ltr.pdf | |
| 04/13/2023 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022287s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022287Orig1s037ltr.pdf | |
| 03/04/2022 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022287s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022287Orig1s035ltr.pdf | |
| 11/27/2020 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022287s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022287Orig1s034ltr.pdf | |
| 09/11/2020 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022287s031lbl.pdf | |
| 06/07/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022287Orig1s029s030ltr.pdf | |
| 06/07/2018 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022287Orig1s029s030ltr.pdf | |
| 10/17/2017 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022287s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022287Orig1s027ltr.pdf | |
| 10/24/2016 | SUPPL-26 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/24/2016 | SUPPL-25 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s025_0208056s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s025,208056Orig1s003ltr.pdf | |
| 07/08/2016 | SUPPL-23 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf | |
| 07/08/2016 | SUPPL-22 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,s022,s023,208056Orig1s001ltr.pdf | |
| 07/08/2016 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,022287Orig1s022,022287Orig1s023,208056Orig1s001ltr.pdf | |
| 02/02/2016 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s020lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s020ltr.pdf | |
| 12/19/2014 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022287s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022287Orig1s019ltr.pdf | |
| 12/16/2015 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022287s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022287Orig1s018ltr.pdf | |
| 08/20/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022287s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022287Orig1s017ltr.pdf | |
| 12/20/2012 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/2012 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s015ltr.pdf | |
| 09/28/2012 | SUPPL-14 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s014ltr.pdf | |
| 05/20/2011 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s012ltr.pdf | |
| 10/28/2011 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s011ltr.pdf | |
| 06/17/2011 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287Orig1s008ltr_replace.pdf | |
| 04/07/2011 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s007ltr.pdf | |
| 09/03/2010 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s005ltr.pdf | |
| 03/19/2010 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s004ltr.pdf | |
| 03/19/2010 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s003ltr.pdf | |
| 06/22/2010 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022287s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022287s038lbl.pdf | |
| 04/13/2023 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022287s037lbl.pdf | |
| 03/04/2022 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022287s035lbl.pdf | |
| 11/27/2020 | SUPPL-34 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022287s034lbl.pdf | |
| 11/27/2020 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022287s034lbl.pdf | |
| 09/11/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022287s031lbl.pdf | |
| 06/07/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf | |
| 06/07/2018 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf | |
| 10/17/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022287s027lbl.pdf | |
| 10/24/2016 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s025_0208056s003lbl.pdf | |
| 07/08/2016 | SUPPL-23 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf | |
| 07/08/2016 | SUPPL-22 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf | |
| 07/08/2016 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s021s022s023,208056s001lbl.pdf | |
| 02/02/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022287s020lbledt.pdf | |
| 12/16/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022287s018lbl.pdf | |
| 12/19/2014 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022287s019lbl.pdf | |
| 08/20/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022287s017lbl.pdf | |
| 09/28/2012 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s014lbl.pdf | |
| 05/03/2012 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022287s015lbl.pdf | |
| 10/28/2011 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s011lbl.pdf | |
| 06/17/2011 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s008lbl.pdf | |
| 05/20/2011 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s012lbl.pdf | |
| 04/07/2011 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022287s007lbl.pdf | |
| 09/03/2010 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf | |
| 09/03/2010 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s005lbl.pdf | |
| 06/22/2010 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s002lbl.pdf | |
| 03/19/2010 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s004lbl.pdf | |
| 03/19/2010 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022287s003lbl.pdf |
DEXILANT
CAPSULE, DELAYED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXILANT | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022287 | TAKEDA PHARMS USA |
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 205205 | MYLAN |
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202294 | PAR PHARM INC |
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202666 | TWI PHARMS |
CAPSULE, DELAYED RELEASE;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXILANT | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022287 | TAKEDA PHARMS USA |
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 205205 | MYLAN |
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202294 | PAR PHARM INC |
| DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202666 | TWI PHARMS |