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Generated: April 27, 2017

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Details for New Drug Application (NDA): 072277

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NDA 072277 describes CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Frontida Biopharm, Par Pharm, Usl Pharma, and Mylan Pharms Inc, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.

Summary for NDA: 072277

Formulation / Manufacturing:see details

Pharmacology for NDA: 072277


Suppliers and Packaging for NDA: 072277

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amitriptyline hydrochloride; chlordiazepoxide
TABLET;ORAL 072277 ANDA Par Pharmaceutical Inc 49884-265 49884-265-01 100 TABLET in 1 BOTTLE (49884-265-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 12.5MG BASE;5MG
Approval Date:May 9, 1988TE:RLD:No

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