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Generated: December 11, 2017

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-eight suppliers are listed for this compound. Additional details are available on the clonazepam profile page.

Summary for 020813

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 020813

Summary 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ORALLY DISINTEGRATING;ORALStrength0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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ORALLY DISINTEGRATING;ORALStrength0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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ORALLY DISINTEGRATING;ORALStrength0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 020813

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-003Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-005Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-004Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-001Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-003Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-005Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-003Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-002Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-002Dec 23, 1997► Subscribe► Subscribe
RocheKLONOPIN RAPIDLY DISINTEGRATINGclonazepamTABLET, ORALLY DISINTEGRATING;ORAL020813-004Dec 23, 1997► Subscribe► Subscribe
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