Approvals (Drugs@FDA)

OMLYCLO

CELLTRION INC · OMALIZUMAB-IGEC

BLA761399Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761399
Sponsor name
CELLTRION INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250307
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      81479
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf
      Date
      20250307
      Type
      Label
    2. ID
      81481
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761399Orig1s000ltr.pdf
      Date
      20250307
      Type
      Letter
    3. ID
      85555
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761399Orig1s000TOC.html
      Date
      20260327
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20251201
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      84727
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s004lbl.pdf
      Date
      20260109
      Type
      Label
    2. ID
      84728
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761399s004lbl.pdf#page=85
      Date
      20260109
      Type
      Medication Guide
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    OMLYCLO
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      OMALIZUMAB-IGEC
      Strength
      300MG/2ML
  2. Product number
    001
    Reference drug
    No
    Brand name
    OMLYCLO
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      OMALIZUMAB-IGEC
      Strength
      75MG/0.5ML
  3. Product number
    002
    Reference drug
    No
    Brand name
    OMLYCLO
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      OMALIZUMAB-IGEC
      Strength
      150MG/ML
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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.