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Generated: April 30, 2017

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Details for New Drug Application (NDA): 084768

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NDA 084768 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, Upsher-smith Labs, Parke Davis, Watson Labs, and Superpharm, and is included in sixty-four NDAs. It is available from thirteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

Summary for NDA: 084768

Formulation / Manufacturing:see details

Pharmacology for NDA: 084768


Suppliers and Packaging for NDA: 084768

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
chlordiazepoxide hydrochloride
CAPSULE;ORAL 084768 ANDA Teva Pharmaceuticals USA, Inc. 0555-0158 0555-0158-02 100 CAPSULE in 1 BOTTLE (0555-0158-02)
chlordiazepoxide hydrochloride
CAPSULE;ORAL 084768 ANDA Teva Pharmaceuticals USA, Inc. 0555-0158 0555-0158-04 500 CAPSULE in 1 BOTTLE (0555-0158-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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