Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761128
Company: NOVARTIS PHARMS CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAKVEO CRIZANLIZUMAB-TMCA 100MG/10ML 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
11/15/2019 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761128s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761128Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761128Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/12/2021 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761128s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761128Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/12/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761128s001lbl.pdf
11/15/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761128s000lbl.pdf

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