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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083386

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NDA 083386 describes CHLORPROMAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Pharm Assoc, Wockhardt, Abraxis Pharm, Marsam Pharms Llc, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Abbott, Cycle Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Purepac Pharm, Pvt Form, Sandoz, Usl Pharma, Vangard, and West Ward, and is included in fifty-four NDAs. It is available from thirteen suppliers. Additional details are available on the CHLORPROMAZINE HYDROCHLORIDE profile page.

The generic ingredient in CHLORPROMAZINE HYDROCHLORIDE is chlorpromazine hydrochloride. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
Summary for 083386
Applicant:Usl Pharma
Ingredient:chlorpromazine hydrochloride
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 083386
Suppliers and Packaging for NDA: 083386
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 083386 ANDA Sandoz Inc 0781-5913 0781-5913-01 100 TABLET, SUGAR COATED in 1 BOTTLE (0781-5913-01)
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 083386 ANDA Upsher-Smith Laboratories, Inc. 0832-0300 0832-0300-00 100 TABLET, SUGAR COATED in 1 BOTTLE (0832-0300-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Farmers Insurance
Daiichi Sankyo

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