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, J And J Consumer Inc, and Merck Sharp Dohme, and is included in nine NDAs. It is available from one supplier. 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-three 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DISCN	Dosage:	TABLET;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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DISCN	Dosage:	TABLET;ORAL			Strength	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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	⤷ Sign Up	⤷ Sign Up
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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