Details for New Drug Application (NDA): 019527

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NDA 019527 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 019527

Tradename:	PEPCID
Applicant:	Salix Pharms
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 019527

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 019527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEPCID	famotidine	FOR SUSPENSION;ORAL	019527	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0147	0574-0147-04	50 mL in 1 BOTTLE (0574-0147-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 2, 1987	TE:		RLD:	Yes

Expired US Patents for NDA 019527

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	4,283,408*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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