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Profile for Tradename: PEPCID COMPLETE

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Pepcid Complete is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for Tradename: PEPCID COMPLETE

Suppliers / Packagers: see list7

Clinical Trials for: PEPCID COMPLETE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
J And J Consumer Inc
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 2000OTCYes6,814,978*PED<disabled>Y<disabled>
J And J Consumer Inc
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 2000OTCYes5,989,588*PED<disabled>Y<disabled>
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Paragraph IV activity for: PEPCID COMPLETE

Drugname Dosage Strength RLD Submissiondate
calcium carbonate/ famotadine/ magnesium hydroxideChewable Tablets800 mg/ 10 mg/ 165 mg (OTC)Pepcid Complete11/1/2004
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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