Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022271
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NESINA | ALOGLIPTIN BENZOATE | EQ 6.25MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
NESINA | ALOGLIPTIN BENZOATE | EQ 12.5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
NESINA | ALOGLIPTIN BENZOATE | EQ 25MG BASE | 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 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022271Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/27/2023 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022271Orig1s015;203414Orig1s016ltr.pdf | |
03/11/2022 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022271s013lbl.pdf 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/2019/022271s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022271Orig1s012, 022426Orig1s012, 203414Orig1s012ltr.pdf | |
12/12/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s011ltr.pdf | |
05/27/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s009ltr.pdf | |
04/19/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/28/2015 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf | |
07/20/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/05/2016 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf | |
08/15/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/26/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/2013 | 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 |
---|---|---|---|---|---|
07/27/2023 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf | |
03/11/2022 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022271s013lbl.pdf | |
07/01/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022271s012lbl.pdf | |
12/12/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s011lbl.pdf | |
05/27/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf | |
04/05/2016 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf | |
08/28/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf | |
01/25/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf |