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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Department of Justice
Johnson and Johnson
Chubb
AstraZeneca
Deloitte
Colorcon
McKinsey
Merck

Generated: April 26, 2018

DrugPatentWatch Database Preview

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. Forty-nine 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 23, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 23, 1997TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 23, 1997TE:RLD:Yes

Expired US Patents for NDA 020813

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche KLONOPIN RAPIDLY DISINTEGRATING clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 020813-003 Dec 23, 1997 ➤ Sign Up ➤ Sign Up
Roche KLONOPIN RAPIDLY DISINTEGRATING clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 020813-003 Dec 23, 1997 ➤ Sign Up ➤ Sign Up
Roche KLONOPIN RAPIDLY DISINTEGRATING clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 020813-001 Dec 23, 1997 ➤ Sign Up ➤ Sign Up
Roche KLONOPIN RAPIDLY DISINTEGRATING clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 020813-005 Dec 23, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Julphar
McKesson
Covington
US Army
Chubb
Citi
Argus Health

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