Approvals (Drugs@FDA)

VANRAFIA

NOVARTIS · ATRASENTAN HYDROCHLORIDE

NDA219208Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA219208
Sponsor name
NOVARTIS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250402
    Review priority
    STANDARD
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      81814
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219208Orig1s001Correctedlbl.pdf
      Date
      20251021
      Type
      Label
    2. ID
      81875
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219208Orig1s001ltr.pdf
      Date
      20251021
      Type
      Letter
    3. ID
      82199
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219208Orig1s000TOC.html
      Date
      20250519
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20251020
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83863
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219208Orig1s001ltr.pdf
      Date
      20251021
      Type
      Letter
    2. ID
      83864
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219208Orig1s001Correctedlbl.pdf
      Date
      20251021
      Type
      Label
    3. ID
      86848
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219208Orig1s001Correctedlbl.pdf#page=12
      Date
      20260811
      Type
      Medication Guide
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    VANRAFIA
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      ATRASENTAN HYDROCHLORIDE
      Strength
      EQ 0.75MG BASE
Harmonized identifiers (openFDA)
Application number
NDA219208
Brand name
VANRAFIA
Generic name
ATRASENTAN
Manufacturer name
Novartis Pharmaceuticals Corporation
Product NDC
0078-1420
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
ATRASENTAN HYDROCHLORIDE
RxCUI
2710454, 2710460
SPL ID
48384e66-f6ff-4b6e-81e2-0a7ac05e8627
SPL set ID
9a7e7f85-bfd0-44a0-beda-3bcfa8215c64
Package NDC
0078-1420-15
UNII
E4G31X93ZA
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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.