Drugs@FDA: FDA Approved Drug Products

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

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

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 206531 AUROBINDO PHARMA LTD
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 075758 DR REDDYS LABS LTD
FAMOTIDINE FAMOTIDINE 10MG TABLET;ORAL Over-the-counter No 075674 MYLAN
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 075312 TEVA
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

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