Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202292
Company: NAPO PHARMS INC
Company: NAPO PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYTESI | CROFELEMER | 125MG | TABLET, DELAYED RELEASE;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
12/31/2012 | 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/2012/202292s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202292Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202292Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202292Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/2024 | SUPPL-9 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202292Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202292Orig1s009ltr.pdf | |
11/16/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202292s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202292Orig1s007ltr.pdf | |
03/06/2018 | SUPPL-6 | Labeling-Proprietary Name Change, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202292Orig1s006ltr.pdf | |
08/20/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/06/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/03/2024 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202292Orig1s009lbl.pdf | |
11/16/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202292s007lbl.pdf | |
03/06/2018 | SUPPL-6 | Labeling-Proprietary Name Change | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf | |
03/06/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf | |
03/06/2018 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf | |
12/31/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202292s000lbl.pdf |