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Last Updated: June 19, 2021

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Details for New Drug Application (NDA): 208086

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NDA 208086 describes GLUCAGON, which is a drug marketed by Amphastar Pharms Inc, Lilly, and Fresenius Kabi Usa, and is included in four NDAs. It is available from four suppliers. Additional details are available on the GLUCAGON profile page.

The generic ingredient in GLUCAGON is glucagon hydrochloride. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.
Summary for 208086
Applicant:Amphastar Pharms Inc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 208086
Suppliers and Packaging for NDA: 208086
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCAGON glucagon INJECTABLE;INJECTION 208086 ANDA Amphastar Pharmaceuticals, Inc. 0548-5850 0548-5850-00 1 KIT in 1 KIT (0548-5850-00) * 1 mL in 1 VIAL (0548-5905-00) * 1 mL in 1 SYRINGE (0548-5831-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/VIAL
Approval Date:Dec 28, 2020TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Johnson and Johnson

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