Details for New Drug Application (NDA): 020801

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NDA 020801 describes PEPCID AC, which is a drug marketed by Kenvue Brands and J And J Consumer Inc and is included in three NDAs. It is available from two suppliers. Additional details are available on the PEPCID AC profile page.

The generic ingredient in PEPCID AC is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty suppliers are listed for this compound. Additional details are available on the famotidine profile page.

Summary for 020801

Tradename:	PEPCID AC
Applicant:	Kenvue Brands
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 020801

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 24, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, CHEWABLE;ORAL			Strength	20MG
Approval Date:	Dec 17, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 020801

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	⤷ Get Started Free	⤷ Get Started Free
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007	⤷ Get Started Free	⤷ Get Started Free
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	⤷ Get Started Free	⤷ Get Started Free
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007	⤷ Get Started Free	⤷ Get Started Free
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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