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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020752
Company: MERCK

Products on NDA 020752

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEPCID RPD	FAMOTIDINE	20MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
PEPCID RPD	FAMOTIDINE	40MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020752

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20752lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20752ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20752s000_PecidTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2001	SUPPL-6	Labeling		Label is not available on this site.
06/06/2002	SUPPL-5	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-4	Labeling		Label is not available on this site.
11/27/2000	SUPPL-3	Labeling		Label is not available on this site.
03/18/1999	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf
01/20/1999	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020752

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2002	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf
05/28/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20752lbl.pdf

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