Details for New Drug Application (NDA): 020325

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NDA 020325 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 020325

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

Pharmacology for NDA: 020325

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 020325

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 020325

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEPCID AC	famotidine	TABLET;ORAL	020325	NDA	Kenvue Brands LLC	16837-855	16837-855-02	2 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCH
PEPCID AC	famotidine	TABLET;ORAL	020325	NDA	Kenvue Brands LLC	16837-855	16837-855-09	1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 28, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 23, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 020325

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	4,283,408*PED	⤷ Get Started Free
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	5,854,267*PED	⤷ Get Started Free
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	5,667,794*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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