FDA.reportPublic FDA data

Application 214231

Type
NDA
Sponsor
ZEALAND PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEGALOGUEDASIGLUCAGONINJECTABLE;INJECTION0.6MG/0.6MLYesNo
002ZEGALOGUE (AUTOINJECTOR)DASIGLUCAGON HYDROCHLORIDESOLUTION;SUBCUTANEOUSEQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
80644-0012ZegaloguedasiglucagonZealand Pharma A/SNDACurrent
80644-0012ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent
80644-0012ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent
80644-0012ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent
80644-0012ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent
80644-0013ZegaloguedasiglucagonZealand Pharma A/SNDACurrent
80644-0013ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent
80644-0013ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent
80644-0013ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent
80644-0013ZegaloguedasiglucagonZealand Pharma US, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67117ORIG2021-04-19
66840ORIG2021-03-23
66833ORIG2021-03-22