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 |
| 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 |