Details for New Drug Application (NDA): 210833

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NDA 210833 describes SYMPAZAN, which is a drug marketed by Otter Pharms 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 SYMPAZAN profile page.

The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.

Summary for 210833

Tradename:	SYMPAZAN
Applicant:	Otter Pharms
Ingredient:	clobazam
Patents:	3

Pharmacology for NDA: 210833

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

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:	RX	Dosage:	FILM;ORAL			Strength	5MG
Approval Date:	Nov 1, 2018	TE:		RLD:	Yes
Patent:	11,541,002	Patent Expiration:	Jan 31, 2040	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING SEIZURES
Patent:	8,603,514	Patent Expiration:	Apr 3, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,765,167	Patent Expiration:	Feb 20, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 210833

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018	8,765,167	⤷ Subscribe
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	8,603,514	⤷ Subscribe
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	8,603,514	⤷ Subscribe
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018	8,603,514	⤷ Subscribe
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	8,765,167	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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