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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 019523

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NDA 019523 describes CYSTEINE HYDROCHLORIDE, which is a drug marketed by Hospira and is included in one NDA. Additional details are available on the CYSTEINE HYDROCHLORIDE profile page.

The generic ingredient in CYSTEINE HYDROCHLORIDE is cysteine hydrochloride. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteine hydrochloride profile page.

Summary for 019523

Tradename:	CYSTEINE HYDROCHLORIDE
Applicant:	Hospira
Ingredient:	cysteine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	7.25% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 22, 1986	TE:		RLD:	Yes

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