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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075400
Company: PERRIGO

Products on ANDA 075400

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075400

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75400taltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2019	SUPPL-35	Labeling-Container/Carton Labels		Label is not available on this site.
10/30/2010	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
11/24/2008	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
12/27/2005	SUPPL-3	Labeling		Label is not available on this site.

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

FAMOTIDINE

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

TABLET;ORAL; 10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	215766	ANNORA PHARMA
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	216030	ASCENT PHARMS INC
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	206531	AUROBINDO PHARMA
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	077367	DR REDDYS LABS LTD
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	077146	GLENMARK PHARMS INC
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	218461	GRAVITI PHARMS
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	217543	MARKSANS PHARMA
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	075512	P AND L
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	075400	PERRIGO
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	215822	VKT PHARMA
PEPCID AC	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	Yes	020325	J AND J CONSUMER INC
PEPCID AC	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	020902	J AND J CONSUMER INC

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