Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021604
Company: MOBERG PHARMA NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ELIXSURE IBUPROFEN 100MG/5ML SUSPENSION;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/07/2004 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21604ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021604s000_Childrens_ElixSureTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021604Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021604Orig1s005ltr.pdf
03/31/2014 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021604Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021604Orig1s004ltr.pdf
01/17/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021604s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021604s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/15/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021604Orig1s005lbl.pdf
03/31/2014 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021604Orig1s004lbl.pdf
01/17/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021604s003lbl.pdf

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