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Serving leading biopharmaceutical companies globally:

McKesson
Cerilliant
Harvard Business School
Mallinckrodt
Federal Trade Commission
Fuji
Covington
Merck
Argus Health
AstraZeneca

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083116

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NDA 083116 describes CHLORDIAZEPOXIDE HYDROCHLORIDE, which is a drug marketed by Roxane, West Ward, Mylan, Teva, Vangard, Ascot, Impax Labs, Barr, Mast Mm, Ferrante, Upsher-smith Labs, Usl Pharma, Lederle, Pioneer Pharms, Halsey, Purepac Pharm, Ivax Sub Teva Pharms, Parke Davis, Watson Labs, and Superpharm, and is included in sixty-four NDAs. It is available from twelve suppliers. Additional details are available on the CHLORDIAZEPOXIDE HYDROCHLORIDE profile page.

The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE is chlordiazepoxide hydrochloride. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

Summary for NDA: 083116

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

Pharmacology for NDA: 083116

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 083116

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORDIAZEPOXIDE HYDROCHLORIDE
chlordiazepoxide hydrochloride
CAPSULE;ORAL 083116 ANDA Teva Pharmaceuticals USA, Inc. 0555-0033 0555-0033-02 100 CAPSULE in 1 BOTTLE (0555-0033-02)
CHLORDIAZEPOXIDE HYDROCHLORIDE
chlordiazepoxide hydrochloride
CAPSULE;ORAL 083116 ANDA Teva Pharmaceuticals USA, Inc. 0555-0033 0555-0033-05 1000 CAPSULE in 1 BOTTLE (0555-0033-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
Chubb
Johnson and Johnson
Harvard Business School
Merck
Novartis
Cerilliant
QuintilesIMS
McKesson
Deloitte

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