Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019651
Company: APIL
Company: APIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ASACOL | MESALAMINE | 400MG | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/01/2020 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019651s028lbl.pdf | |
| 10/01/2020 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019651s028lbl.pdf | |
| 07/27/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019651s027lbl.pdf | |
| 05/27/2015 | SUPPL-25 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf | |
| 10/18/2013 | SUPPL-24 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf | |
| 05/24/2010 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf | |
| 09/14/2009 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019651s020lbl.pdf |