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Last Updated: June 4, 2020

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Details for New Drug Application (NDA): 084115

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NDA 084115 describes CHLORPROMAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Pharm Assoc, Wockhardt, Abraxis Pharm, Dr Reddys, Marsam Pharms Llc, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Abbott, Amneal Pharms Co, Cycle Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Purepac Pharm, Pvt Form, Sandoz, Upsher Smith Labs, Vangard, West Ward, Zydus, and Hikma, and is included in fifty-six NDAs. It is available from fifteen suppliers. Additional details are available on the CHLORPROMAZINE HYDROCHLORIDE profile page.

The generic ingredient in CHLORPROMAZINE HYDROCHLORIDE is chlorpromazine hydrochloride. There are twenty-four drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
Summary for 084115
Applicant:Upsher Smith Labs
Ingredient:chlorpromazine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 084115
Suppliers and Packaging for NDA: 084115
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 084115 ANDA Sandoz Inc 0781-5917 0781-5917-01 100 TABLET, SUGAR COATED in 1 BOTTLE (0781-5917-01)
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 084115 ANDA Upsher-Smith Laboratories, Inc. 0832-0304 0832-0304-00 100 TABLET, SUGAR COATED in 1 BOTTLE (0832-0304-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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