Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022348
Company: APOTEX

• Summary Review

Products on NDA 22348

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

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