Approvals (Drugs@FDA)

IMDELLTRA

AMGEN INC · TARLATAMAB-DLLE

BLA761344Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761344
Sponsor name
AMGEN INC
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20251119
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      84237
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761344s001lbl.pdf
      Date
      20251120
      Type
      Label
    2. ID
      84250
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761344Orig1s001ltr.pdf
      Date
      20251121
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260911
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      87193
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761344s002lbl.pdf
      Date
      20260915
      Type
      Label
    2. ID
      87196
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761344Orig1s002ltr.pdf
      Date
      20260915
      Type
      Letter
    3. ID
      87220
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761344s002lbl.pdf#page=36
      Date
      20260915
      Type
      Medication Guide
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240516
    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
      78485
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf
      Date
      20240516
      Type
      Label
    2. ID
      78506
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761344Orig1s000ltr.pdf
      Date
      20240520
      Type
      Letter
    3. ID
      78915
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761344Orig1s000TOC.html
      Date
      20240627
      Type
      Review
    4. ID
      86135
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/763144Orig1s001.pdf
      Date
      20260602
      Type
      Review
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    IMDELLTRA
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TARLATAMAB-DLLE
      Strength
      1MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    IMDELLTRA
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      TARLATAMAB-DLLE
      Strength
      10MG
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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.