Details for New Drug Application (NDA): 020520

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NDA 020520 describes ZANTAC 75, which is a drug marketed by Chattem Sanofi and is included in two NDAs. Additional details are available on the ZANTAC 75 profile page.

The generic ingredient in ZANTAC 75 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 020520

Tradename:	ZANTAC 75
Applicant:	Chattem Sanofi
Ingredient:	ranitidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 75MG BASE
Approval Date:	Dec 19, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020520

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ZANTAC 75	ranitidine hydrochloride	TABLET;ORAL	020520-001	Dec 19, 1995	4,128,658	⤷ Get Started Free
Chattem Sanofi	ZANTAC 75	ranitidine hydrochloride	TABLET;ORAL	020520-001	Dec 19, 1995	4,521,431*PED	⤷ Get Started Free
Chattem Sanofi	ZANTAC 75	ranitidine hydrochloride	TABLET;ORAL	020520-001	Dec 19, 1995	4,880,636*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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