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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Merck
McKesson
Mallinckrodt
Dow
QuintilesIMS
Julphar
Citi
Covington

Generated: December 12, 2017

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

Pharmacology for NDA: 071297

Ingredient-typeBenzodiazepines

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 0378-0211-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05)
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 071297 ANDA Mylan Pharmaceuticals Inc. 0378-0211 0378-0211-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE;10MG
Approval Date:Dec 10, 1986TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE;5MG
Approval Date:Dec 10, 1986TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Cerilliant
McKesson
Chinese Patent Office
Argus Health
Deloitte
Express Scripts
Healthtrust
Novartis
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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