Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005010
Company: VALIDUS PHARMS

• Medication Guide

Products on NDA 5010

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEMEROL	MEPERIDINE HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	Yes	No
DEMEROL	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEMEROL	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEMEROL	MEPERIDINE HYDROCHLORIDE	100MG	TABLET;ORAL	Discontinued	None	Yes	No
DEMEROL	MEPERIDINE HYDROCHLORIDE	50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SYRUP;ORAL	Discontinued	None	No	No
DEMEROL	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEMEROL	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 005010

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2021	SUPPL-59	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf
03/04/2021	SUPPL-59	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf
10/07/2019	SUPPL-58	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf
10/07/2019	SUPPL-58	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf
09/18/2018	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf
09/18/2018	SUPPL-56	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf
08/16/2017	SUPPL-55	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005010s055lbl.pdf
08/16/2017	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005010s055lbl.pdf
12/16/2016	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf
12/16/2016	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf
12/16/2016	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/005010s054lbl.pdf
10/31/2011	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s051lbl.pdf
04/11/2011	SUPPL-50	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s050lbl.pdf
03/05/2009	SUPPL-49	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005010s049lbl.pdf