Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209449
Company: CYCLE PHARMS LTD
Company: CYCLE PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITYR | NITISINONE | 2MG | TABLET;ORAL | Prescription | None | Yes | No |
| NITYR | NITISINONE | 5MG | TABLET;ORAL | Prescription | None | Yes | No |
| NITYR | NITISINONE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/26/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209449s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209449Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209449Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/05/2018 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209449s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209449Orig1s006ltr.pdf | |
| 09/02/2020 | SUPPL-5 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209449s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209449Orig1s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/02/2020 | SUPPL-5 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209449s005lbl.pdf | |
| 11/05/2018 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209449s006lbl.pdf | |
| 07/26/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209449s000lbl.pdf |
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