Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021431
Company: FOREST LABS
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| CAMPRAL | ACAMPROSATE CALCIUM | 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21431lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21431ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-431_Campral.cfm |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |