Approvals (Drugs@FDA)

NILOTINIB D-TARTRATE

CIPLA · NILOTINIB D-TARTRATE

NDA218922Drug (NDA)Discontinued
Open FDA's page for this record
Application number
NDA218922
Sponsor name
CIPLA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250219
    Review priority
    STANDARD
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
    Application docs
    1. ID
      81291
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218922s000lbl.pdf
      Date
      20250220
      Type
      Label
    2. ID
      81305
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218922Orig1s000ltr.pdf
      Date
      20250221
      Type
      Letter
    3. ID
      85098
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218922Orig1s000TOC.html
      Date
      20260220
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250710
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      82787
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218922Orig1s001ltr.pdf
      Date
      20250711
      Type
      Letter
    2. ID
      82812
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218922s001lbl.pdf
      Date
      20250711
      Type
      Label
    3. ID
      82813
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218922s001lbl.pdf#page=38
      Date
      20250711
      Type
      Medication Guide
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    NILOTINIB D-TARTRATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      NILOTINIB D-TARTRATE
      Strength
      EQ 150MG BASE
  2. Product number
    003
    Reference drug
    Yes
    Brand name
    NILOTINIB D-TARTRATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      NILOTINIB D-TARTRATE
      Strength
      EQ 200MG BASE
  3. Product number
    001
    Reference drug
    Yes
    Brand name
    NILOTINIB D-TARTRATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      NILOTINIB D-TARTRATE
      Strength
      EQ 50MG BASE
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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.