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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022450
Company: MALLINCKRODT HOSP

Summary Review

Products on NDA 022450

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OFIRMEV	ACETAMINOPHEN	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022450

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022450s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450_ofirmev_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022450Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022450s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022450Orig1s011ltr.pdf
01/27/2017	SUPPL-10	Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022450s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022450Orig1s010ltr.pdf
10/18/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf
10/18/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022450Orig1s005,s006ltr.pdf
04/19/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/05/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022450

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022450s011lbl.pdf
01/27/2017	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022450s010lbl.pdf
01/27/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022450s010lbl.pdf
10/18/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf
10/18/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022450s005s006lbl.pdf
11/02/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf

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