Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020249
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER FAMOTIDINE 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
02/18/1994 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
11/05/2007 SUPPL-13 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
03/14/2001 SUPPL-12 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-11 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/2001/020249_s011_PEPCID INJECTION.pdf
04/25/2001 SUPPL-10 Labeling

Label is not available on this site.

03/18/1999 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019510S026_pepcid.pdf
11/12/1997 SUPPL-8 Labeling

Label is not available on this site.

08/12/1998 SUPPL-7 Labeling

Label is not available on this site.

08/19/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-5 Labeling

Label is not available on this site.

03/03/1997 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1995 SUPPL-2 Labeling

Label is not available on this site.

06/29/1995 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-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf
06/06/2002 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf
03/14/2001 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English