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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019527
Company: SALIX PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID FAMOTIDINE 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION;ORAL Discontinued None Yes No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
02/02/1987 ORIG-1 Approval Type 3 - New Dosage Form 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
08/15/2019 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019527s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019527Orig1s031ltr.pdf
11/05/2007 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019527s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019527s028ltr.pdf
11/24/2004 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19527s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19527s027ltr.pdf
03/14/2001 SUPPL-25 Labeling

Label is not available on this site.
06/06/2002 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf
04/25/2001 SUPPL-23 Labeling

Label is not available on this site.
11/27/2000 SUPPL-22 Labeling

Label is not available on this site.
10/13/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
03/18/1999 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf
10/08/1998 SUPPL-19 Labeling

Label is not available on this site.
10/28/1997 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
08/22/1997 SUPPL-17 Labeling

Label is not available on this site.
08/12/1998 SUPPL-16 Labeling

Label is not available on this site.
02/01/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
03/29/1996 SUPPL-14 Labeling

Label is not available on this site.
03/29/1996 SUPPL-13 Labeling

Label is not available on this site.
03/29/1996 SUPPL-12 Labeling

Label is not available on this site.
11/30/1990 SUPPL-9 Labeling

Label is not available on this site.
08/22/1997 SUPPL-8 Labeling

Label is not available on this site.
12/10/1991 SUPPL-7 Labeling

Label is not available on this site.
11/30/1990 SUPPL-5 Labeling

Label is not available on this site.
11/30/1990 SUPPL-4 Labeling

Label is not available on this site.
10/28/1988 SUPPL-3 Labeling

Label is not available on this site.
09/29/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
11/23/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/15/2019 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019527s031lbl.pdf
11/05/2007 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019527s028lbl.pdf
11/24/2004 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19527s027lbl.pdf
06/06/2002 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf
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