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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 020813

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NDA 020813 describes KLONOPIN RAPIDLY DISINTEGRATING, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the KLONOPIN RAPIDLY DISINTEGRATING profile page.

The generic ingredient in KLONOPIN RAPIDLY DISINTEGRATING is clonazepam. There are ten drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the clonazepam profile page.

Summary for 020813

Tradename:	KLONOPIN RAPIDLY DISINTEGRATING
Applicant:	Roche
Ingredient:	clonazepam
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020813

Anticonvulsants
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1997	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020813

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-001	Dec 23, 1997	⤷ Try a Trial	⤷ Try a Trial
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-002	Dec 23, 1997	⤷ Try a Trial	⤷ Try a Trial
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-002	Dec 23, 1997	⤷ Try a Trial	⤷ Try a Trial
Roche	KLONOPIN RAPIDLY DISINTEGRATING	clonazepam	TABLET, ORALLY DISINTEGRATING;ORAL	020813-001	Dec 23, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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