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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019012
Company: KENVUE BRANDS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOTRIN IB IBUPROFEN 200MG TABLET;ORAL Over-the-counter None Yes No
MOTRIN MIGRAINE PAIN IBUPROFEN 200MG TABLET;ORAL Discontinued None No No
NUPRIN IBUPROFEN 200MG TABLET;ORAL Discontinued None No No
NUPRIN IBUPROFEN 200MG TABLET;ORAL Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/16/2021 SUPPL-59 Labeling-Package Insert Label (PDF) Label for Motrin IB https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019012Orig1s059lbl.pdf
01/07/2021 SUPPL-58 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019012Orig1s058lbl.pdf
03/16/2017 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf
03/16/2017 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf
03/16/2017 SUPPL-56 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf
08/18/2016 SUPPL-55 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019012Orig1s055lbl.pdf
10/21/2010 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019012s046lbl.pdf
09/07/2001 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19012s28lbl.pdf
02/25/2000 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016_Ibuprofen_prntlbl.pdf
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