Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021830
Company: APIL
Company: APIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ASACOL HD | MESALAMINE | 800MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/29/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021830lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021830s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021830TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021830s000_SUMR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/01/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021830s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021830Orig1s019ltr.pdf | |
10/01/2020 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021830Orig1s016ltr.pdf | |
05/21/2020 | SUPPL-15 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s015lbl.pdf | ||
04/18/2018 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021830s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021830Orig1s012ltr.pdf | |
07/27/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021830s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf | |
05/05/2016 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021830Orig1s010ltr.pdf | |
10/22/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/13/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/18/2013 | SUPPL-6 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021830Orig1s006ltr.pdf | |
05/24/2010 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021830s005ltr.pdf | |
04/23/2009 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021830s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/01/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021830s019lbl.pdf | |
10/01/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s016lbl.pdf | |
10/01/2020 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s016lbl.pdf | |
05/21/2020 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s015lbl.pdf | |
04/18/2018 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021830s012lbl.pdf | |
07/27/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021830s011lbl.pdf | |
05/05/2016 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf | |
10/18/2013 | SUPPL-6 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf | |
05/24/2010 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf | |
04/23/2009 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf | |
05/29/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021830lbl.pdf |
ASACOL HD
TABLET, DELAYED RELEASE;ORAL; 800MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASACOL HD | MESALAMINE | 800MG | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021830 | APIL |
MESALAMINE | MESALAMINE | 800MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 203286 | ZYDUS PHARMS |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English