Details for New Drug Application (NDA): 215602

NDA 215602 describes FLEQSUVY, which is a drug marketed by Azurity and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the FLEQSUVY profile page.

The generic ingredient in FLEQSUVY is baclofen. There are twenty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 215602

Tradename:	FLEQSUVY
Applicant:	Azurity
Ingredient:	baclofen
Patents:	2

Pharmacology for NDA: 215602

Mechanism of Action

GABA A Agonists GABA B Agonists

Medical Subject Heading (MeSH) Categories for 215602

GABA-B Receptor Agonists

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 215602

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLEQSUVY	baclofen	SUSPENSION;ORAL	215602	NDA AUTHORIZED GENERIC	Wilshire Pharmaceuticals, Inc.	52536-600	52536-600-11	1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLE
FLEQSUVY	baclofen	SUSPENSION;ORAL	215602	NDA AUTHORIZED GENERIC	Wilshire Pharmaceuticals, Inc.	52536-600	52536-600-12	1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/5ML
Approval Date:	Feb 4, 2022	TE:	AB	RLD:	Yes
Patent:		Patent Expiration:	Sep 29, 2037	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Sep 8, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	INDICATED FOR THE TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS

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