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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 210833


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NDA 210833 describes SYMPAZAN, which is a drug marketed by Aquestive Therap and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SYMPAZAN profile page.

The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 210833
Tradename:SYMPAZAN
Applicant:Aquestive Therap
Ingredient:clobazam
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 210833
Suppliers and Packaging for NDA: 210833
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYMPAZAN clobazam FILM;ORAL 210833 NDA Aquestive Therapeutics 10094-205 10094-205-60 60 POUCH in 1 PACKAGE (10094-205-60) > 1 FILM in 1 POUCH (10094-205-01)
SYMPAZAN clobazam FILM;ORAL 210833 NDA Aquestive Therapeutics 10094-210 10094-210-60 60 POUCH in 1 PACKAGE (10094-210-60) > 1 FILM in 1 POUCH (10094-210-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;ORALStrength5MG
Approval Date:Nov 1, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 3, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 20, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM;ORALStrength10MG
Approval Date:Nov 1, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 3, 2024Product Flag?YSubstance Flag?Delist Request?

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