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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020902
Company: J AND J CONSUMER INC

Products on NDA 020902

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020902

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/05/1999	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902_Pepcid.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2006	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020902s009LTR.pdf
10/27/2004	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf
01/31/2002	SUPPL-5	Labeling		Label is not available on this site.
07/13/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020902

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020902A_Pepcid_prntlbl.pdf

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

PEPCID AC

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 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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