Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020801
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID AC FAMOTIDINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
PEPCID AC FAMOTIDINE 20MG TABLET, CHEWABLE;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/24/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20801ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20801.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/11/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/01/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/17/2007 SUPPL-12 Efficacy-New Dosing Regimen Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020801s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020801Orig1s012.pdf
10/27/2004 SUPPL-10 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-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20801s7ltr.pdf
03/29/2001 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20801S4ltr.pdf
04/26/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/06/2000 SUPPL-2 Labeling

Label is not available on this site.

08/20/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2001 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf
09/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf

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, CHEWABLE;ORAL; 20MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
PEPCID AC FAMOTIDINE 20MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 020801 J AND J CONSUMER INC

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