Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021604
Company: MOBERG PHARMA NORTH
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 |