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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203414
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KAZANO ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE EQ 12.5MG BASE;500MG TABLET;ORAL Prescription None Yes No
KAZANO ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE EQ 12.5MG BASE;1GM TABLET;ORAL Prescription None 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
01/25/2013 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203414s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203414Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203414Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/11/2022 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203414s013lbl.pdf#page=32 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022271Orig1s013; 022426Orig1s014; 203414Orig1s013ltr.pdf
07/01/2019 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203414s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022271Orig1s012, 022426Orig1s012, 203414Orig1s012ltr.pdf
12/12/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203414Orig1s008,s009ltr.pdf
12/12/2016 SUPPL-8 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203414Orig1s008,s009ltr.pdf
02/15/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203414s007lbl.pdf
08/28/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203414s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf
08/21/2014 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/2016/203414s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf
10/17/2013 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
03/11/2022 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203414s013lbl.pdf#page=32
07/01/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203414s012lbl.pdf
02/15/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203414s007lbl.pdf
12/12/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s008s009lbl.pdf
12/12/2016 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s008s009lbl.pdf
04/05/2016 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203414s003lbl.pdf
08/28/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203414s005lbl.pdf
01/25/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203414s000lbl.pdf
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