Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022426
Company: TAKEDA PHARMS USA
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HYDROCHLORIDE | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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HYDROCHLORIDE | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|
03/11/2022 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022426s014lbl.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/2019/022426s012lbl.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 |
---|---|---|---|---|---|
03/11/2022 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022426s014lbl.pdf | |
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 |