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Last Updated: November 4, 2024

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, Dash Pharms, Dava Pharms Inc, Gd Searle Llc, Purepac Pharm, Quantum Pharmics, Rising, Usl Pharma, Warner Chilcott, Watson Labs, Aurobindo Pharma, Aurolife Pharma Llc, Corepharma, Lederle, Novitium Pharma, Sun Pharm Inds Ltd, and Taro, and is included in fifty-eight NDAs. It is available from seven 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. Seven suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.
Summary for 071858
Tradename:CLORAZEPATE DIPOTASSIUM
Applicant:Aurobindo Pharma
Ingredient:clorazepate dipotassium
Patents:0
Pharmacology for NDA: 071858
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 Aurolife Pharma LLC 13107-282 13107-282-01 100 TABLET in 1 BOTTLE (13107-282-01)
CLORAZEPATE DIPOTASSIUM clorazepate dipotassium TABLET;ORAL 071858 ANDA Aurolife Pharma LLC 13107-282 13107-282-05 500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05)

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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