Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214231
Company: ZEALAND PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEGALOGUE DASIGLUCAGON HYDROCHLORIDE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
ZEGALOGUE (AUTOINJECTOR) DASIGLUCAGON HYDROCHLORIDE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/22/2021 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214231Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/22/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf

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