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Generated: December 10, 2018

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Details for New Drug Application (NDA): 083116

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NDA 083116 describes CHLORDIAZEPOXIDE HYDROCHLORIDE, which is a drug marketed by Ascot, Barr, Ferrante, Halsey, Impax Labs, Ivax Sub Teva Pharms, Lederle, Mast Mm, Mylan, Parke Davis, Pioneer Pharms, Purepac Pharm, Roxane, Superpharm, Teva, Upsher Smith Labs, Upsher-smith Labs, Usl Pharma, Vangard, Watson Labs, and West Ward, and is included in sixty-four NDAs. It is available from ten 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. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.
Summary for 083116
Tradename:CHLORDIAZEPOXIDE HYDROCHLORIDE
Applicant:Barr
Ingredient:chlordiazepoxide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 083116
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)

Profile 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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