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Serving leading biopharmaceutical companies globally:

Covington
Federal Trade Commission
Colorcon
Johnson and Johnson
Moodys
McKinsey
US Department of Justice
Fish and Richardson
QuintilesIMS
Harvard Business School

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071443

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NDA 071443 describes PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Mylan, Par Pharm, Sandoz, Sun Pharm Industries, and Watson Labs, and is included in thirty-five NDAs. It is available from one supplier. Additional details are available on the PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.
Summary for 071443
Tradename:PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:amitriptyline hydrochloride; perphenazine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071443
Ingredient-typePhenothiazines
Suppliers and Packaging for NDA: 071443
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 071443 ANDA Mylan Pharmaceuticals Inc. 0378-0042 0378-0042-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0042-01)
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; perphenazine TABLET;ORAL 071443 ANDA Mylan Pharmaceuticals Inc. 0378-0073 0378-0073-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0073-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;4MG
Approval Date:Nov 10, 1988TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;2MG
Approval Date:Nov 10, 1988TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;4MG
Approval Date:Nov 10, 1988TE:RLD:No

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Express Scripts
Queensland Health
US Department of Justice
Merck
McKinsey
Argus Health
Cerilliant

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