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Generated: June 18, 2019

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Details for New Drug Application (NDA): 017533

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NDA 017533 describes KLONOPIN, which is a drug marketed by Roche and is included in two NDAs. It is available from two suppliers. 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. Forty-seven suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
Summary for 017533
Tradename:KLONOPIN
Applicant:Roche
Ingredient:clonazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017533
Medical Subject Heading (MeSH) Categories for 017533
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 Genentech, Inc. 0004-0058 0004-0058-01 100 TABLET in 1 BOTTLE, PLASTIC (0004-0058-01)
KLONOPIN clonazepam TABLET;ORAL 017533 NDA Genentech, Inc. 0004-0068 0004-0068-01 100 TABLET in 1 BOTTLE, PLASTIC (0004-0068-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 017533

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

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