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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210134


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NDA 210134 describes BAQSIMI, which is a drug marketed by Amphastar Pharms Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the BAQSIMI profile page.

The generic ingredient in BAQSIMI is glucagon. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glucagon profile page.
Summary for 210134
Tradename:BAQSIMI
Applicant:Amphastar Pharms Inc
Ingredient:glucagon
Patents:3
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210134
Suppliers and Packaging for NDA: 210134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BAQSIMI glucagon POWDER;NASAL 210134 NDA Eli Lilly and Company 0002-6145 0002-6145-11 1 TUBE in 1 CARTON (0002-6145-11) / 1 BOTTLE, UNIT-DOSE in 1 TUBE (0002-6145-02) / 1 POWDER in 1 BOTTLE, UNIT-DOSE (0002-6145-01)
BAQSIMI glucagon POWDER;NASAL 210134 NDA Eli Lilly and Company 0002-6145 0002-6145-27 2 TUBE in 1 CARTON (0002-6145-27) / 1 BOTTLE, UNIT-DOSE in 1 TUBE (0002-6145-02) / 1 POWDER in 1 BOTTLE, UNIT-DOSE (0002-6145-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;NASALStrength3MG
Approval Date:Jul 24, 2019TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 16, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEVERE HYPOGLYCEMIA IN PATIENTS WITH DIABETES
Patent:⤷  Try a TrialPatent Expiration:Sep 23, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jan 3, 2038Product Flag?YSubstance Flag?Delist Request?

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