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Details for Generic Name: calcium carbonate; famotidine; magnesium hydroxide

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Calcium carbonate; famotidine; magnesium hydroxide is the generic ingredient in two branded drugs marketed by Perrigo R And D and J And J Consumer Inc, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are two hundred and forty-nine drug master file entries for calcium carbonate; famotidine; magnesium hydroxide. One supplier is listed for this compound.

Summary for Generic Name: calcium carbonate; famotidine; magnesium hydroxide

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list249
Suppliers / Packaging: see list7

Clinical Trials for: calcium carbonate; famotidine; magnesium hydroxide

A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Status: Completed Condition: Heartburn

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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
PEPCID COMPLETE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 2000OTCYes5,989,588*PED<disabled>Y<disabled>
Perrigo R And D
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL077355-001Feb 6, 2008OTCNo<disabled><disabled>
J And J Consumer Inc
PEPCID COMPLETE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 2000OTCYes6,814,978*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: calcium carbonate; famotidine; magnesium hydroxide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
PEPCID COMPLETE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 20004,283,408*PED<disabled>
J And J Consumer Inc
PEPCID COMPLETE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 20005,075,114*PED<disabled>
J And J Consumer Inc
PEPCID COMPLETE
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 20005,229,137*PED<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

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