Approvals (Drugs@FDA)

TRUQAP

ASTRAZENECA · CAPIVASERTIB

NDA218197Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218197
Sponsor name
ASTRAZENECA
Submissions
  1. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20260916
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      87214
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s006ltr.pdf
      Date
      20260921
      Type
      Letter
    2. ID
      87234
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218197s006lbl.pdf
      Date
      20260922
      Type
      Label
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20260612
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      86260
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s004ltr.pdf
      Date
      20260616
      Type
      Letter
    2. ID
      86275
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218197s004lbl.pdf
      Date
      20260616
      Type
      Label
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20231116
    Review priority
    PRIORITY
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      76598
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf
      Date
      20231117
      Type
      Label
    2. ID
      76619
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/218197Orig1s000ltr.pdf
      Date
      20231117
      Type
      Letter
    3. ID
      76873
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/218197Orig1s000TOC.html
      Date
      20231215
      Type
      Review
  4. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20250213
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      81258
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218197Orig1s002ltr.pdf
      Date
      20250214
      Type
      Letter
    2. ID
      81263
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s002lbl.pdf
      Date
      20250218
      Type
      Label
  5. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20260527
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      86065
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s005ltr.pdf
      Date
      20260529
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20251114
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      84175
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s003lbl.pdf
      Date
      20251117
      Type
      Label
    2. ID
      84183
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218197Orig1s003ltr.pdf
      Date
      20251118
      Type
      Letter
  7. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240923
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      79709
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218197s001lbl.pdf
      Date
      20240924
      Type
      Label
    2. ID
      79729
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218197Orig1s001ltr.pdf
      Date
      20240924
      Type
      Letter
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    TRUQAP
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      CAPIVASERTIB
      Strength
      200MG
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    TRUQAP
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      CAPIVASERTIB
      Strength
      160MG
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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.