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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072278

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NDA 072278 describes CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Anda Repository, Mylan Pharms Inc, Par Pharm, Usl Pharma, Watson Labs, and Watson Labs Teva, 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 072278

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

Pharmacology for NDA: 072278

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 072278

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 072278 ANDA Par Pharmaceutical Inc 49884-266 49884-266-01 100 TABLET in 1 BOTTLE (49884-266-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 25MG BASE;10MG
Approval Date:May 9, 1988TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
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Harvard Business School
Dow

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