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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761119
Company: Lundbeck Seattle BioPharmaceuticals, Inc.
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VYEPTI EPTINEZUMAB-JJMR 100MG/ML 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
02/21/2020 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761119s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761119Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761119Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/21/2022 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761119s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761119Orig1s006ltr.pdf
09/24/2021 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761119s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761119Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/21/2022 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761119s006lbl.pdf
09/24/2021 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761119s002lbl.pdf
09/24/2021 SUPPL-2 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761119s002lbl.pdf
02/21/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761119s000lbl.pdf
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