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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 085580

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NDA 085580 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 Pharma Ltd, Hikma, Hospira, Marsam Pharms Llc, Mylan Labs Ltd, Nexus, Sagent, Smith And Nephew, Teva Parenteral, Viwit Pharm, Wyeth Ayerst, Ajanta Pharma Ltd, Bionpharma, Chartwell Rx, Duramed Pharms Barr, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Norvium Bioscience, Novitium Pharma, Teva Pharms, and Zydus Lifesciences, and is included in forty-four 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-eight suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.

Summary for 085580

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 5MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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