Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022000
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIALDA | MESALAMINE | 1.2GM | TABLET, 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 |
|---|---|---|---|---|---|---|---|
| 01/16/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022000s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022000s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022000s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022000Orig1s027ltr.pdf | |
| 11/16/2022 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022000s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022000Orig1s025ltr.pdf | |
| 11/01/2021 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022000s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022000Orig1s023ltr.pdf | |
| 05/25/2021 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022000Orig1s022lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022000Orig1s022ltr.pdf | |
| 12/17/2020 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022000s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022000Orig1s021ltr.pdf | |
| 10/01/2020 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022000s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022000Orig1s020ltr.pdf | |
| 06/26/2020 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022000s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022000Orig1s019ltr.pdf | |
| 07/18/2019 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022000s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022000Orig1s018ltr.pdf | |
| 05/23/2018 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022000s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022000Orig1s017ltr.pdf | |
| 07/27/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s030,022000Orig1s016ltr.pdf | |
| 08/22/2017 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022000Orig1s015ltr.pdf | |
| 10/16/2014 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022000s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022000Orig1s013ltr.pdf | |
| 03/14/2014 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/16/2013 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s011ltr.pdf | |
| 08/09/2013 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf | |
| 08/28/2013 | SUPPL-9 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s009ltr.pdf | |
| 08/09/2013 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf | |
| 07/14/2011 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022000s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022000s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf | |
| 09/22/2010 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022000s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022000s003ltr.pdf | |
| 10/30/2009 | SUPPL-2 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022000s002lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022000s027lbl.pdf | |
| 11/16/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022000s025lbl.pdf | |
| 11/01/2021 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022000s023lbl.pdf | |
| 05/25/2021 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022000Orig1s022lblrpl.pdf | |
| 12/17/2020 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022000s021lbl.pdf | |
| 10/01/2020 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022000s020lbl.pdf | |
| 06/26/2020 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022000s019lbl.pdf | |
| 07/18/2019 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022000s018lbl.pdf | |
| 05/23/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022000s017lbl.pdf | |
| 08/22/2017 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s015lbl.pdf | |
| 07/27/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s016lbl.pdf | |
| 10/16/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022000s013lbl.pdf | |
| 12/16/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s011lbl.pdf | |
| 08/28/2013 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000Orig1s009lbl.pdf | |
| 08/09/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf | |
| 08/09/2013 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf | |
| 07/14/2011 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022000s005lbl.pdf | |
| 09/22/2010 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022000s003lbl.pdf | |
| 10/30/2009 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022000s002lbl.pdf | |
| 01/16/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf |
LIALDA
TABLET, DELAYED RELEASE;ORAL; 1.2GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIALDA | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022000 | TAKEDA PHARMS USA |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 203817 | ACTAVIS LABS FL |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 216334 | ANNORA PHARMA |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 217337 | SINOTHERAPEUTICS INC |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211858 | SUN PHARM |
| MESALAMINE | MESALAMINE | 1.2GM | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091640 | ZYDUS PHARMS |