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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201849

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GLUCAGON (GLUCAGON HYDROCHLORIDE)
EQ 1MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: GLUCAGON HYDROCHLORIDE
Proprietary Name: GLUCAGON
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR, INTRAVENOUS
Strength: EQ 1MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201849
Product Number: 001
Approval Date: May 8, 2015
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLUCAGON (GLUCAGON HYDROCHLORIDE)
EQ 1MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: GLUCAGON HYDROCHLORIDE
Proprietary Name: GLUCAGON
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 1MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201849
Product Number: 002
Approval Date: Sep 19, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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