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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 218912

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NDA 218912 describes PROCHLORPERAZINE MALEATE, which is a drug marketed by Ajanta Pharma Ltd, Amneal, Bionpharma, Chartwell Rx, Duramed Pharms Barr, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Leading, Norvium Bioscience, Novitium Pharma, Teva Pharms, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from seventeen 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-eight suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.

Summary for 218912

Tradename:	PROCHLORPERAZINE MALEATE
Applicant:	Leading
Ingredient:	prochlorperazine maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Sep 30, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Sep 30, 2024	TE:	AB	RLD:	No

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