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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021604
Company: MOBERG PHARMA NORTH

Products on NDA 021604

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021604

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

Labels for NDA 021604

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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