Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020325
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 Yes No
PEPCID AC FAMOTIDINE 20MG TABLET;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
04/28/1995 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2019 SUPPL-33 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020325Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020325Orig1s033ltr.pdf
08/01/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/08/2016 SUPPL-30 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020325Orig1s030ltr.pdf
05/05/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/09/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/06/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/20/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/01/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/11/2012 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf
06/09/2006 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020325s019LTR.pdf
10/27/2004 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf
09/23/2003 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20325se2-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020325s015TOC.cfm
03/01/2002 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s13ltr.pdf
04/05/2000 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/10/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1998 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/09/1998 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.

09/26/1997 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/23/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/03/1996 SUPPL-3 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s3ltr.pdf
10/02/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 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
04/09/2019 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020325Orig1s033lbl.pdf
06/08/2016 SUPPL-30 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf
10/11/2012 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf
09/23/2003 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.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; 20MG
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.

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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