Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212726
Company: GENENTECH INC
Company: GENENTECH INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROZLYTREK | ENTRECTINIB | 100MG | CAPSULE;ORAL | Prescription | TBD | TBD | No |
| ROZLYTREK | ENTRECTINIB | 200MG | CAPSULE;ORAL | Prescription | TBD | TBD | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/15/2019 | ORIG-1 | Approval | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212726s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212726Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212725Orig1s000,%20212726Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/15/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212726s000lbl.pdf |
ROZLYTREK
There are no Therapeutic Equivalents.
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