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Details for New Drug Application (NDA): 084887

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NDA 084887 describes CHLORDIAZEPOXIDE HYDROCHLORIDE, which is a drug marketed by Hikma Pharms Llc, Roxane, Mylan, Teva, Vangard, Ascot, Impax Labs, Barr, Mast Mm, Ferrante, Sandoz, 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 eleven 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. Sixteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

Summary for NDA: 084887

chlordiazepoxide hydrochloride

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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