Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019510
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID FAMOTIDINE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
PEPCID PRESERVATIVE FREE FAMOTIDINE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
11/04/1986 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19510lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2007 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf
08/01/2002 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/14/2001 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF
06/06/2002 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019510_s028_Pepcid Injection.pdf
04/25/2001 SUPPL-27 Labeling

Label is not available on this site.

03/18/1999 SUPPL-26 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019510S026_pepcid.pdf
01/28/1999 SUPPL-25 Labeling

Label is not available on this site.

12/19/1997 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1997 SUPPL-23 Labeling

Label is not available on this site.

05/16/1997 SUPPL-22 Labeling

Label is not available on this site.

05/06/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1998 SUPPL-20 Labeling

Label is not available on this site.

01/30/1996 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1995 SUPPL-18 Labeling

Label is not available on this site.

06/29/1995 SUPPL-17 Labeling

Label is not available on this site.

06/29/1995 SUPPL-16 Labeling

Label is not available on this site.

05/08/1996 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/30/1990 SUPPL-12 Labeling

Label is not available on this site.

05/16/1997 SUPPL-11 Labeling

Label is not available on this site.

12/10/1991 SUPPL-10 Labeling

Label is not available on this site.

06/29/1995 SUPPL-9 Labeling

Label is not available on this site.

11/30/1990 SUPPL-8 Labeling

Label is not available on this site.

11/30/1990 SUPPL-7 Labeling

Label is not available on this site.

10/28/1988 SUPPL-6 Labeling

Label is not available on this site.

01/07/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/23/1988 SUPPL-4 Labeling

Label is not available on this site.

06/03/1987 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1987 SUPPL-2 Labeling

Label is not available on this site.

12/12/1986 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
11/05/2007 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf
06/06/2002 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf
03/14/2001 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF
11/04/1986 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19510lbl.pdf

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