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Calcium carbonate; famotidine; magnesium hydroxide - Generic Drug Details

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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 fifty-two drug master file entries for calcium carbonate; famotidine; magnesium hydroxide. Thirty suppliers are 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 list252
Suppliers / Packaging: see list30
Formulation / Manufacturing:see details

Clinical Trials for: calcium carbonate; famotidine; magnesium hydroxide

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, 2000OTCYes6,814,978*PED<disabled>Y<disabled>
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>
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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, 20005,989,588*PED<disabled>
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, 20005,229,137*PED<disabled>
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