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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084113

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NDA 084113 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 084113

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antiemetics
Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 084113

Ingredient-typePhenothiazines

Suppliers and Packaging for NDA: 084113

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 084113 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7683 0615-7683-39 30 TABLET, SUGAR COATED in 1 BLISTER PACK (0615-7683-39)
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 084113 ANDA Sandoz Inc 0781-5915 0781-5915-01 100 TABLET, SUGAR COATED in 1 BOTTLE (0781-5915-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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