Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077355
Company: PERRIGO R AND D

Products on ANDA 077355

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077355

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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
PEPCID COMPLETE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE;ORAL	Over-the-counter	Yes	020958	J AND J CONSUMER INC