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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Federal Trade Commission
Cerilliant
Farmers Insurance
Boehringer Ingelheim
Mallinckrodt
Queensland Health
Healthtrust
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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040101

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NDA 040101 describes PROCHLORPERAZINE MALEATE, which is a drug marketed by Duramed Pharms Barr, Ivax Sub Teva Pharms, Mylan, Sandoz, and Teva Pharms, and is included in eight NDAs. It is available from twenty suppliers. Additional details are available on the PROCHLORPERAZINE MALEATE profile page.

The generic ingredient in PROCHLORPERAZINE MALEATE is prochlorperazine maleate. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.
Summary for 040101
Tradename:PROCHLORPERAZINE MALEATE
Applicant:Sandoz
Ingredient:prochlorperazine maleate
Patents:0
Therapeutic Class:Antiemetics
Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 040101
Ingredient-typePhenothiazines
Suppliers and Packaging for NDA: 040101
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCHLORPERAZINE MALEATE prochlorperazine maleate TABLET;ORAL 040101 ANDA Sandoz Inc 0781-5020 0781-5020-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5020-01)
PROCHLORPERAZINE MALEATE prochlorperazine maleate TABLET;ORAL 040101 ANDA Sandoz Inc 0781-5020 0781-5020-05 500 TABLET, FILM COATED in 1 BOTTLE (0781-5020-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 19, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 19, 1996TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Jul 19, 1996TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Citi
Cerilliant
US Department of Justice
Express Scripts
Accenture
Julphar
Johnson and Johnson

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