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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071297

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NDA 071297 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 071297

Tradename:	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Applicant:	Mylan Pharms Inc
Ingredient:	amitriptyline hydrochloride; chlordiazepoxide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 071297

Ingredient-type	Benzodiazepines

Suppliers and Packaging for NDA: 071297

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	071297	ANDA	Mylan Pharmaceuticals Inc.	0378-0211	N	0378-0211-01
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	071297	ANDA	Mylan Pharmaceuticals Inc.	0378-0211	N	0378-0211-05

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE;10MG
Approval Date:	Dec 10, 1986	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG BASE;5MG
Approval Date:	Dec 10, 1986	TE:		RLD:	No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office

Moodys

Daiichi Sankyo

AstraZeneca

Teva

Mallinckrodt

Johnson and Johnson

Argus Health

Covington

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