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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 202395

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NDA 202395 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from twenty-one suppliers. Additional details are available on the ZIPRASIDONE HYDROCHLORIDE profile page.

The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.

Summary for 202395

Tradename:	ZIPRASIDONE HYDROCHLORIDE
Applicant:	Mylan
Ingredient:	ziprasidone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Oct 10, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Oct 10, 2013	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 60MG BASE
Approval Date:	Oct 10, 2013	TE:		RLD:	No

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