An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022348
Company: CUMBERLAND PHARMS

Summary Review

Products on NDA 022348

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022348

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
05/11/2023	SUPPL-24	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022348s024lbl.pdf
11/19/2021	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022348s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022348Orig1s021ltr.pdf
12/06/2022	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022348Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022348Orig1s020ltr.pdf
04/28/2021	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022348s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022348Orig1s018ltr.pdf
07/22/2019	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022348s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022348Orig1s014ltr.pdf
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.

Labels for NDA 022348

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2023	SUPPL-24	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022348s024lbl.pdf
12/06/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022348Orig1s020lbl.pdf
11/19/2021	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022348s021lbl.pdf
04/28/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022348s018lbl.pdf
07/22/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022348s014lbl.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-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

Top