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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020249
Company: MERCK SHARP DOHME

Products on NDA 020249

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FREE IN PLASTIC CONTAINER	FAMOTIDINE	0.4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020249

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.

Labels for NDA 020249

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

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