Last Updated: September 1, 2026

Details for New Drug Application (NDA): 088597

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NDA 088597 describes PROCHLORPERAZINE EDISYLATE, which is a drug marketed by 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, Watson Labs, Wyeth Ayerst, and Alpharma Us Pharms, and is included in twenty-four NDAs. It is available from sixteen suppliers. Additional details are available on the PROCHLORPERAZINE EDISYLATE profile page.

The generic ingredient in PROCHLORPERAZINE EDISYLATE is prochlorperazine edisylate. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the prochlorperazine edisylate profile page.

Summary for 088597

Tradename:	PROCHLORPERAZINE EDISYLATE
Applicant:	Morton Grove
Ingredient:	prochlorperazine edisylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	Oct 25, 1984	TE:		RLD:	No

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