Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020958
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID COMPLETE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG 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
10/16/2000 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20958ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-958_Pepcid.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2016 SUPPL-25 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020958Orig1s025ltr.pdf
07/14/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/20/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/07/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/30/2013 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020958Orig1s018ltr.pdf
04/01/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/18/2008 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020958s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020958Orig1s015.pdf
06/09/2006 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020958s013LTR.pdf
07/18/2005 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020958s012ltr.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
11/05/2003 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20958slr007ltr.pdf
11/22/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/2001 SUPPL-2 Manufacturing (CMC)-Formulation Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020958_S002_PEPCIDTOC.cfm
09/24/2001 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
06/08/2016 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf
07/30/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf
07/18/2005 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf
11/06/2001 SUPPL-2 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf
10/16/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf

PEPCID COMPLETE

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; 800MG;10MG;165MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG TABLET, CHEWABLE;ORAL Over-the-counter No 077355 PERRIGO R AND D
FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG TABLET, CHEWABLE;ORAL Over-the-counter No 204782 PERRIGO R AND D
PEPCID COMPLETE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800MG;10MG;165MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 020958 J AND J CONSUMER INC

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