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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761063
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMGALITY GALCANEZUMAB-GNLM 120MG/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
09/27/2018 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761063Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2022 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761063s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761063Orig1s006ltr.pdf
12/05/2019 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761063Orig1s004ltr.pdf
06/04/2019 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761063Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/24/2022 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761063s006lbl.pdf
05/24/2022 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761063s006lbl.pdf
12/05/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s004lbl.pdf
06/04/2019 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s003lbl.pdf
09/27/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf
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