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Abbreviated New Drug Application (ANDA): 208086
Company: AMPHASTAR PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUCAGON GLUCAGON 1MG/VIAL INJECTABLE;INJECTION Prescription AP 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
12/28/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208086Orig1s000ltr.pdf

GLUCAGON

INJECTABLE;INJECTION; 1MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUCAGON GLUCAGON 1MG/VIAL INJECTABLE;INJECTION Prescription No AP 208086 AMPHASTAR PHARMS INC
GLUCAGON GLUCAGON 1MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 020928 LILLY
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