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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 213368


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NDA 213368 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 213368
Tradename:CHLORPROMAZINE HYDROCHLORIDE
Applicant:Zydus
Ingredient:chlorpromazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213368
Suppliers and Packaging for NDA: 213368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 213368 ANDA Major Pharmaceuticals 0904-7129 0904-7129-61 100 BLISTER PACK in 1 CARTON (0904-7129-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride TABLET;ORAL 213368 ANDA Major Pharmaceuticals 0904-7130 0904-7130-06 50 BLISTER PACK in 1 CARTON (0904-7130-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 17, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 17, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 17, 2020TE:ABRLD:No

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