اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CALDOLOR از شرکت CUMBERLAND PHARMS
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022348lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-18 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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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