U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761059
Company: SAMSUNG BIOEPIS CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HADLIMA ADALIMUMAB-BWWD 40MG/0.8ML INJECTABLE;INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/23/2019 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761059s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761059Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/15/2022 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761059Orig1s005ltr.pdf
06/17/2022 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761059Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/15/2022 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s005lbl.pdf
06/17/2022 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf
06/17/2022 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf
07/23/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761059s000lbl.pdf
Back to Top