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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217847

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NDA 217847 describes PROCHLORPERAZINE MALEATE, which is a drug marketed by Ajanta Pharma Ltd, Amneal, 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 seventeen NDAs. It is available from twenty suppliers. Additional details are available on the PROCHLORPERAZINE MALEATE profile page.

The generic ingredient in PROCHLORPERAZINE MALEATE 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 217847

Tradename:	PROCHLORPERAZINE MALEATE
Applicant:	Dr Reddys Labs Sa
Ingredient:	prochlorperazine maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	May 19, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	May 19, 2025	TE:	AB	RLD:	No

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