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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Citi
Farmers Insurance
Deloitte
Cipla
US Department of Justice
Mallinckrodt
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071858

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NDA 071858 describes CLORAZEPATE DIPOTASSIUM, which is a drug marketed by Able, Am Therap, Aurolife Pharma Llc, Dava Pharms Inc, Gd Searle Llc, Mylan, Purepac Pharm, Quantum Pharmics, Usl Pharma, Warner Chilcott, Watson Labs, Lederle, Sun Pharm Inds Ltd, and Taro Pharm, and is included in fifty-eight NDAs. It is available from eight suppliers. Additional details are available on the CLORAZEPATE DIPOTASSIUM profile page.

The generic ingredient in CLORAZEPATE DIPOTASSIUM is clorazepate dipotassium. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.
Summary for 071858
Tradename:CLORAZEPATE DIPOTASSIUM
Applicant:Mylan
Ingredient:clorazepate dipotassium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071858
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 071858
Suppliers and Packaging for NDA: 071858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLORAZEPATE DIPOTASSIUM clorazepate dipotassium TABLET;ORAL 071858 ANDA Mylan Pharmaceuticals Inc. 0378-0030 0378-0030-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-0030-05)
CLORAZEPATE DIPOTASSIUM clorazepate dipotassium TABLET;ORAL 071858 ANDA Mylan Pharmaceuticals Inc. 0378-0030 0378-0030-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0030-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jul 17, 1987TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3.75MG
Approval Date:Jul 17, 1987TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Jul 17, 1987TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
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UBS
Argus Health
QuintilesIMS
Merck
Julphar
Federal Trade Commission
AstraZeneca

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