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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022348
Company: APOTEX

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.html 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
01/23/2026	SUPPL-28	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022348s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/022348Orig1s028ltr.pdf
11/21/2024	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022348s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022348Orig1s027ltr.pdf
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
01/23/2026	SUPPL-28	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022348s028lbl.pdf
11/21/2024	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022348s027lbl.pdf
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

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