FDA Approval for KRAZATI (ADAGRASIB) issued to MIRATI THERAPEUTICS, INC
$MRTX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 216340
Company: MIRATI THERAPEUTICS, INC
Company: MIRATI THERAPEUTICS, INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KRAZATI (ADAGRASIB) | ADAGRASIB | 200mg | TABLET;ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/12/2022 | ORIG-1 | Approval | Efficacy | STANDARD |
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