Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022450
Company: MALLINCKRODT HOSP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OFIRMEV ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
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.cfm 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 Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data 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.

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 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022450s010lbl.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
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

OFIRMEV

SOLUTION;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 202605 CUSTOPHARM INC
ACETAMINOPHEN ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204052 SANDOZ INC
OFIRMEV ACETAMINOPHEN 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 022450 MALLINCKRODT HOSP

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