Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022519
Company: HORIZON
Company: HORIZON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DUEXIS | FAMOTIDINE; IBUPROFEN | 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
04/23/2011 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022519s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519_duexis_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022519Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022519Orig1s013ltr.pdf | |
07/22/2019 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022519s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022519Orig1s012ltr.pdf | |
06/07/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022519Orig1s011ltr.pdf | |
07/08/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022519s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022519Orig1s009ltr.pdf | |
03/04/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/28/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/31/2013 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/18/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/13/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf | |
04/28/2021 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf | |
07/22/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022519s012lbl.pdf | |
06/07/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf | |
05/09/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022519s009lbl.pdf | |
04/23/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022519s000lbl.pdf |