Drugs@FDA: FDA-Approved Drugs
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/31/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/01/2020 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019651s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019651Orig1s028ltr.pdf | |
07/27/2017 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019651s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf | |
09/16/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/27/2015 | SUPPL-25 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019651Orig1s025ltr.pdf | |
10/18/2013 | SUPPL-24 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019651Orig1s024ltr.pdf | |
05/24/2010 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019651s023ltr.pdf | |
09/14/2009 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019651s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019651s020ltr.pdf | |
04/10/2007 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019651s016LTR.pdf |
09/05/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/25/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/14/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
08/14/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
07/08/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/31/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/25/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/30/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
08/19/1997 | SUPPL-5 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/asacol_19651s5.cfm |
05/06/1996 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/06/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/1995 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/27/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
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 |