Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022519
Company: HORIZON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUEXIS FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET;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
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

DUEXIS

TABLET;ORAL; 26.6MG;800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DUEXIS FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET;ORAL Prescription Yes AB 022519 HORIZON
IBUPROFEN AND FAMOTIDINE FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET;ORAL Prescription No AB 211890 ALKEM LABS LTD
IBUPROFEN AND FAMOTIDINE FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET;ORAL Prescription No AB 211278 TEVA PHARMS USA

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