Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022348
Company: CUMBERLAND PHARMS
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 |
---|---|---|---|---|---|
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. |
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 |