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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 085579

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NDA 085579 describes PROCHLORPERAZINE, which is a drug marketed by Alpharma Us Pharms, Baxter Hlthcare, Able, Cosette, Watson Labs, Morton Grove, Amneal, Avet Lifesciences, Caplin, Eugia Pharma, Gland, Hikma, Hospira, Marsam Pharms Llc, Mylan Labs Ltd, Nexus, Sagent, Smith And Nephew, Somerset Theraps Llc, Teva Parenteral, Viwit Pharm, Wyeth Ayerst, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Leading, Novitium Pharma, Pharmobedient, Teva Pharms, and Zydus Lifesciences, and is included in forty-eight NDAs. It is available from one supplier. Additional details are available on the PROCHLORPERAZINE profile page.

The generic ingredient in PROCHLORPERAZINE is prochlorperazine maleate. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.

Summary for 085579

Tradename:	PROCHLORPERAZINE
Applicant:	Watson Labs
Ingredient:	prochlorperazine maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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