Details for New Drug Application (NDA): 218623

NDA 218623 describes LIBERVANT, which is a drug marketed by Aquestive and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the LIBERVANT profile page.

The generic ingredient in LIBERVANT is diazepam. There are eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diazepam profile page.

Summary for 218623

Tradename:	LIBERVANT
Applicant:	Aquestive
Ingredient:	diazepam
Patents:	1

Pharmacology for NDA: 218623

Medical Subject Heading (MeSH) Categories for 218623

Adjuvants, Anesthesia

Anesthetics, Intravenous

Anti-Anxiety Agents

Anticonvulsants

Antiemetics

GABA Modulators

Hypnotics and Sedatives

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 218623

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIBERVANT	diazepam	FILM;BUCCAL	218623	NDA	AQUESTIVE THERAPEUTICS	10094-305	10094-305-02	2 POUCH in 1 BOX (10094-305-02) / 1 FILM in 1 POUCH (10094-305-01)
LIBERVANT	diazepam	FILM;BUCCAL	218623	NDA	AQUESTIVE THERAPEUTICS	10094-307	10094-307-02	2 POUCH in 1 BOX (10094-307-02) / 1 FILM in 1 POUCH (10094-307-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM;BUCCAL			Strength	5MG
Approval Date:	Apr 26, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 26, 2027
Regulatory Exclusivity Use:	NEW PRODUCT
Patent:		Patent Expiration:	Jun 18, 2038	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM;BUCCAL			Strength	7.5MG
Approval Date:	Apr 26, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 26, 2027
Regulatory Exclusivity Use:	NEW PRODUCT

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