Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218003
Company: CONTRACT PHARMACAL

Products on ANDA 218003

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
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218003

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2024	ORIG-1	Approval		STANDARD		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; 20MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	215766	ANNORA PHARMA
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	216030	ASCENT PHARMS INC
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	206531	AUROBINDO PHARMA
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	218003	CONTRACT PHARMACAL
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	077367	DR REDDYS LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	090837	GLENMARK PHARMS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	218461	GRAVITI PHARMS
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	217543	MARKSANS PHARMA
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	077351	PERRIGO R AND D
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	215822	VKT PHARMA
PEPCID AC	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	Yes	020325	KENVUE BRANDS

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	218003	CONTRACT PHARMACAL
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
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	KENVUE BRANDS