Approvals (Drugs@FDA)

IMAAVY

JANSSEN BIOTECH · NIPOCALIMAB-AAHU

BLA761430Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761430
Sponsor name
JANSSEN BIOTECH
Submissions
  1. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260824
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      87028
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761430s002lbl.pdf
      Date
      20260825
      Type
      Label
    2. ID
      87062
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761430Orig1s002ltr.pdf
      Date
      20260828
      Type
      Letter
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250429
    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
      82076
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761430s000lbl.pdf
      Date
      20250430
      Type
      Label
    2. ID
      82140
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761430Orig1s000ltr.pdf
      Date
      20250505
      Type
      Letter
    3. ID
      82433
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761430Orig1s000TOC.html
      Date
      20250602
      Type
      Review
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    IMAAVY
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      NIPOCALIMAB-AAHU
      Strength
      1200MG/6.5ML(185MG/ML)
  2. Product number
    001
    Reference drug
    No
    Brand name
    IMAAVY
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      NIPOCALIMAB-AAHU
      Strength
      300MG/1.62ML(185MG/ML)
Harmonized identifiers (openFDA)
Application number
BLA761430
Brand name
IMAAVY
Generic name
NIPOCALIMAB-AAHU
Manufacturer name
Janssen Biotech, Inc.
Product NDC
57894-800, 57894-801
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
NIPOCALIMAB
RxCUI
2712699, 2712706, 2712708, 2712709
SPL ID
38376edc-230b-4b2b-8bb6-55b9dccea7a5
SPL set ID
8886274c-f2b2-48af-85c1-2f90bfe304b8
Package NDC
57894-801-01, 57894-800-01
UNII
87M90CV8NC
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.