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
CAMPRAL از شرکت FOREST LABS
New Drug Application (NDA): 021431
Company: FOREST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAMPRAL | ACAMPROSATE CALCIUM | 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued |
None |
Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/29/2004 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21431lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/10/2015 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/2012 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021431s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021431s015ltr.pdf |
||
| 12/13/2010 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021431s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021431s013ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/30/2012 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021431s015lbl.pdf | |
| 12/13/2010 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021431s013lbl.pdf | |
| 07/29/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21431lbl.pdf |
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