Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020865
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MAXALT-MLT | RIZATRIPTAN BENZOATE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| MAXALT-MLT | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/01/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020864s023,020865s024lbl.pdf | |
| 10/01/2019 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020864s023,020865s024lbl.pdf | |
| 12/16/2011 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf | |
| 12/16/2011 | SUPPL-20 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf | |
| 12/16/2011 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf | |
| 12/16/2011 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf | |
| 12/16/2011 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf | |
| 08/12/2010 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf | |
| 06/29/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf |