Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022348
Company: CUMBERLAND PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALDOLOR IBUPROFEN 400MG/4ML (100MG/ML) SOLUTION;INTRAVENOUS Discontinued None No No
CALDOLOR IBUPROFEN 800MG/8ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
CALDOLOR IBUPROFEN 800MG/200ML (4MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
06/11/2009 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/2009/022348lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022348s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022348_caldolor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022348s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-10 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022348s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022348Orig1s010ltr.pdf
11/20/2015 SUPPL-5 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022348s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022348Orig1s005ltr.pdf
03/09/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/27/2015 SUPPL-3 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022348Orig1s003ltr.pdf
01/14/2014 SUPPL-2 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
05/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022348s010lbl.pdf
05/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022348s010lbl.pdf
05/09/2016 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022348s010lbl.pdf
11/20/2015 SUPPL-5 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022348s005lbl.pdf
06/11/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022348lbl.pdf

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