Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 090283
Company: SUN PHARM INDS LTD

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

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2009	ORIG-1	Approval				Label is not available on this site.

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2020	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/02/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	206531	AUROBINDO PHARMA LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	077367	DR REDDYS LABS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	077351	PERRIGO R AND D
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	090283	SUN PHARM INDS LTD
FAMOTIDINE	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	No	090837	WOCKHARDT
PEPCID AC	FAMOTIDINE	20MG	TABLET;ORAL	Over-the-counter	Yes	020325	J AND J CONSUMER INC

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	206531	AUROBINDO PHARMA LTD
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	077367	DR REDDYS LABS LTD
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	090283	SUN PHARM INDS LTD
FAMOTIDINE	FAMOTIDINE	10MG	TABLET;ORAL	Over-the-counter	No	077146	WOCKHARDT
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