Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077355
Company: PERRIGO R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG TABLET, CHEWABLE;ORAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/06/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077355ltr.pdf

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 800MG;10MG;165MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG TABLET, CHEWABLE;ORAL Over-the-counter No 077355 PERRIGO R AND D
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG TABLET, CHEWABLE;ORAL Over-the-counter No 204782 PERRIGO R AND D
PEPCID COMPLETE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 020958 J AND J CONSUMER INC

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