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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 218623


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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-eight 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
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:RXDosage:FILM;BUCCALStrength5MG
Approval Date:Apr 26, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 26, 2027
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jun 18, 2038Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrength7.5MG
Approval Date:Apr 26, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 26, 2027
Regulatory Exclusivity Use:NEW PRODUCT

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