Details for New Drug Application (NDA): 019462

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NDA 019462 describes PEPCID, which is a drug marketed by Salix Pharms, Merck, Bausch, Kenvue Brands, J And J Consumer Inc, and Merck Sharp Dohme, and is included in nine NDAs. Additional details are available on the PEPCID profile page.

The generic ingredient in PEPCID is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 019462

Tradename:	PEPCID
Applicant:	Bausch
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 019462

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 15, 1986	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 15, 1986	TE:		RLD:	Yes

Expired US Patents for NDA 019462

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-001	Oct 15, 1986	4,283,408*PED	⤷ Get Started Free
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986	4,283,408*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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