Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020049
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PENTASA | MESALAMINE | 250MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| PENTASA | MESALAMINE | 500MG | CAPSULE, EXTENDED 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 |
|---|---|---|---|---|---|---|---|
| 05/10/1993 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020049a_052292_biopharmrev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020049s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020049Orig1s040ltr.pdf | |
| 11/16/2022 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020049s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020049Orig1s038ltr.pdf | |
| 11/01/2021 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020049s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020049Orig1s036ltr.pdf | |
| 05/25/2021 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020049s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020049Orig1s035ltr.pdf | |
| 10/29/2020 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020049Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020049Orig1s034ltr.pdf | |
| 10/01/2020 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020049s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020049Orig1s033ltr.pdf | |
| 07/16/2019 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020049s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020049Orig1s032ltr.pdf | |
| 05/30/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020049s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020049Origs031ltr.pdf | |
| 07/27/2017 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s030,022000Orig1s016ltr.pdf | |
| 08/22/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s028ltr.pdf | |
| 08/05/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020049s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020049Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020049Orig1s027.pdf | |
| 12/16/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s026ltr.pdf | |
| 07/23/2013 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s025ltr.pdf | |
| 06/26/2007 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020049s019ltr.pdf |
| 06/27/2006 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020049s017ltr.pdf |
| 07/08/2004 | SUPPL-15 | Manufacturing (CMC)-Control |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20049scs015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020049_S015_PENTASA.pdf |
| 09/03/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1999 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20046S006_Pentasa.cfm | |
| 08/05/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/19/1998 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020049s040lbl.pdf | |
| 11/16/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020049s038lbl.pdf | |
| 11/01/2021 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020049s036lbl.pdf | |
| 05/25/2021 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020049s035lbl.pdf | |
| 10/29/2020 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020049Orig1s034lbl.pdf | |
| 10/01/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020049s033lbl.pdf | |
| 07/16/2019 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020049s032lbl.pdf | |
| 05/30/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020049s031lbl.pdf | |
| 08/22/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s028lbl.pdf | |
| 07/27/2017 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s030lbl.pdf | |
| 08/05/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020049s027lbl.pdf | |
| 12/16/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf | |
| 07/23/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s025lbl.pdf | |
| 09/10/1999 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_prntlbl.pdf |
PENTASA
CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | MESALAMINE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214585 | SUN PHARM |
| PENTASA | MESALAMINE | 500MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020049 | TAKEDA PHARMS USA |