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
CAMBIA از شرکت ASSERTIO
New Drug Application (NDA): 022165
Company: ASSERTIO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAMBIA | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 06/17/2009 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022165Orig1s013,s014ltr.pdf |
||
| 04/28/2021 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022165Orig1s013,s014ltr.pdf |
||
| 03/20/2017 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022165Orig1s012ltr.pdf |
||
| 05/09/2016 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022165Orig1s011ltr.pdf |
||
| 12/10/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/2011 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022165s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf | |
| 04/28/2021 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf | |
| 03/20/2017 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf | |
| 05/09/2016 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf | |
| 06/17/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf |
CAMBIA
FOR SOLUTION;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAMBIA | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription | Yes | AB | 022165 | ASSERTIO |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription | No | AB | 202964 | PAR FORM |
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