Approvals (Drugs@FDA)

RASONQUE

REVOLUTION MEDICINES · DARAXONRASIB

NDA220910Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA220910
Sponsor name
REVOLUTION MEDICINES
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260826
    Review priority
    PRIORITY
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      87060
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220910Orig1s000ltr.pdf
      Date
      20260828
      Type
      Letter
    2. ID
      87078
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220910Orig1s000lbl.pdf
      Date
      20260901
      Type
      Label
    3. ID
      87090
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220910Orig1s000lbl.pdf#page=20
      Date
      20260901
      Type
      Medication Guide
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    RASONQUE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      DARAXONRASIB
      Strength
      100MG
  2. Product number
    002
    Reference drug
    Yes
    Brand name
    RASONQUE
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      DARAXONRASIB
      Strength
      150MG
Harmonized identifiers (openFDA)
Application number
NDA220910
Brand name
RASONQUE
Generic name
DARAXONRASIB
Manufacturer name
Revolution Medicines, Inc.
Product NDC
85219-101, 85219-104
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DARAXONRASIB
RxCUI
2750160, 2750166, 2750168, 2750170
SPL ID
107d4cd9-2e5e-419d-9449-7ef84f5fbcc9
SPL set ID
13a65923-d072-4dac-8620-8eabbf8c3641
Package NDC
85219-101-01, 85219-104-01
UNII
B6T47Y2UAP
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.