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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 019593

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NDA 019593 describes ZANTAC IN PLASTIC CONTAINER, which is a drug marketed by Pai Holdings Pharm and is included in one NDA. Additional details are available on the ZANTAC IN PLASTIC CONTAINER profile page.

The generic ingredient in ZANTAC IN PLASTIC CONTAINER is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 019593

Tradename:	ZANTAC IN PLASTIC CONTAINER
Applicant:	Pai Holdings Pharm
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/100ML
Approval Date:	Dec 17, 1986	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Sep 27, 1991	TE:		RLD:	No

Expired US Patents for NDA 019593

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-002	Sep 27, 1991	4,128,658	⤷ Get Started Free
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986	4,128,658	⤷ Get Started Free
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986	4,521,431*PED	⤷ Get Started Free
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986	4,585,790*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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