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Last Updated: March 19, 2024

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, Genus, Pharm Assoc, Wockhardt, Abraxis Pharm, Dr Reddys, Eugia Pharma, Marsam Pharms Llc, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Abbott, Alembic, Amneal Pharms Co, Appco, Chartwell Rx, Cycle, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, Lederle, Lupin, MSN, Purepac Pharm, Pvt Form, Sandoz, Sun Pharm, Teva Pharms, Upsher Smith Labs, Vangard, West Ward, Zydus, and Hikma, and is included in sixty-seven NDAs. It is available from twenty-five 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. Twenty-five suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
Summary for 084115
Tradename:CHLORPROMAZINE HYDROCHLORIDE
Applicant:Upsher Smith Labs
Ingredient:chlorpromazine hydrochloride
Patents:0
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 Upsher-Smith Laboratories, LLC 0832-6021 0832-6021-00 100 TABLET, FILM COATED in 1 BOTTLE (0832-6021-00)
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 084115 ANDA Upsher-Smith Laboratories, LLC 0832-6021 0832-6021-01 1 BLISTER PACK in 1 CARTON (0832-6021-01) / 100 TABLET, FILM COATED in 1 BLISTER PACK (0832-6021-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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