Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022426
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 25MG BASE;EQ 15MG BASE TABLET;ORAL Prescription None Yes No
OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 25MG BASE;EQ 30MG BASE TABLET;ORAL Prescription None Yes No
OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 25MG BASE;EQ 45MG BASE TABLET;ORAL Prescription None Yes Yes
OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 15MG BASE TABLET;ORAL Prescription None Yes No
OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 30MG BASE TABLET;ORAL Prescription None Yes No
OSENI ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE EQ 12.5MG BASE;EQ 45MG BASE TABLET;ORAL Prescription 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
01/25/2013 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022426s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022426Orig1s000Ltr_1_.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022426Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2019 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022271Orig1s012, 022426Orig1s012, 203414Orig1s012ltr.pdf
12/21/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022426s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022426Orig1s010ltr.pdf
12/12/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022426Orig1s006,s009ltr.pdf
12/12/2016 SUPPL-6 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022426Orig1s006,s009ltr.pdf
08/28/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022426s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf
03/17/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/05/2016 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf
08/15/2013 SUPPL-1 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
07/01/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf
12/21/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022426s010lbl.pdf
12/12/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf
04/05/2016 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s003lbl.pdf
08/28/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022426s005lbl.pdf
01/25/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022426s000lbl.pdf

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