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 one supplier. 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. Nine 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

Pharmacology for NDA: 210134

Physiological Effect	Decreased GI Motility Decreased GI Smooth Muscle Tone Decreased Glycolysis Increased Gluconeogenesis Increased Glycogenolysis

Medical Subject Heading (MeSH) Categories for 210134

Gastrointestinal Agents
Hormones

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	Amphastar Pharmaceuticals, Inc.	0548-8351	0548-8351-01	1 TUBE in 1 CARTON (0548-8351-01) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE
BAQSIMI	glucagon	POWDER;NASAL	210134	NDA	Amphastar Pharmaceuticals, Inc.	0548-8352	0548-8352-02	2 TUBE in 1 CARTON (0548-8352-02) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;NASAL			Strength	3MG
Approval Date:	Jul 24, 2019	TE:		RLD:	Yes
Patent:	10,213,487	Patent Expiration:	Feb 16, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SEVERE HYPOGLYCEMIA IN PATIENTS WITH DIABETES
Patent:	10,765,602	Patent Expiration:	Sep 23, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	12,370,241	Patent Expiration:	Feb 16, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SEVERE HYPOGLYCEMIA IN PATIENTS WITH DIABETES

Expired US Patents for NDA 210134

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amphastar Pharms Inc	BAQSIMI	glucagon	POWDER;NASAL	210134-001	Jul 24, 2019	6,938,798	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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