Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208685
Company: PTC THERAP
Company: PTC THERAP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMFLAZA | DEFLAZACORT | 22.75MG/ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
02/09/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208684Orig1s000,208685Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/29/2021 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208684s005,208685s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208684Orig1s005, 208685Orig1s005ltr.pdf | |
07/10/2020 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208684s004,208685s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208684Orig1s004,208685Orig1s004ltr.pdf | |
06/07/2019 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208684s003,208685s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208684Orig1s003,208685Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/29/2021 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208684s005,208685s005lbl.pdf | |
07/10/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208684s004,208685s004lbl.pdf | |
06/07/2019 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208684s003,208685s003lbl.pdf | |
02/09/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf |