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Last Updated: April 27, 2024

Details for New Drug Application (NDA): 017533

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NDA 017533 describes KLONOPIN, which is a drug marketed by Cheplapharm and Roche and is included in two NDAs. It is available from one supplier. Additional details are available on the KLONOPIN profile page.

The generic ingredient in KLONOPIN 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 017533

Tradename:	KLONOPIN
Applicant:	Cheplapharm
Ingredient:	clonazepam
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 017533

Medical Subject Heading (MeSH) Categories for 017533

Anticonvulsants
GABA Modulators

Suppliers and Packaging for NDA: 017533

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KLONOPIN	clonazepam	TABLET;ORAL	017533	NDA	H2-Pharma, LLC	61269-605	61269-605-10	100 TABLET in 1 BOTTLE, PLASTIC (61269-605-10)
KLONOPIN	clonazepam	TABLET;ORAL	017533	NDA	H2-Pharma, LLC	61269-610	61269-610-10	100 TABLET in 1 BOTTLE, PLASTIC (61269-610-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017533

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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