Application 021842
- Type
- NDA
- Sponsor
- TAKEDA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | 500MG;EQ 15MG BASE | Yes | No |
| 002 | ACTOPLUS MET | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | 850MG;EQ 15MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64764-155 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-155 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-155 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-155 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-155 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-158 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-158 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-158 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-158 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-158 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78944 | SUPPL | 2024-07-01 |
| 78943 | SUPPL | 2024-07-01 |
| 50916 | SUPPL | 2017-12-27 |
| 50862 | SUPPL | 2017-12-26 |
| 50861 | SUPPL | 2017-12-26 |
| 46730 | SUPPL | 2017-01-09 |
| 46729 | SUPPL | 2017-01-09 |
| 46143 | SUPPL | 2016-12-14 |
| 46138 | SUPPL | 2016-12-13 |
| 37746 | SUPPL | 2014-08-20 |
| 6285 | SUPPL | 2014-08-19 |
| 37744 | SUPPL | 2012-05-22 |
| 28696 | SUPPL | 2012-05-22 |
| 16441 | SUPPL | 2012-05-22 |
| 28692 | SUPPL | 2012-05-18 |
| 6282 | SUPPL | 2012-05-18 |
| 37745 | SUPPL | 2011-08-04 |
| 28695 | SUPPL | 2011-08-04 |
| 16443 | SUPPL | 2011-08-04 |
| 6284 | SUPPL | 2011-08-04 |
| 28694 | SUPPL | 2010-08-11 |
| 6283 | SUPPL | 2009-11-25 |
| 44154 | ORIG | 2009-11-12 |
| 28693 | SUPPL | 2009-10-26 |
| 16442 | SUPPL | 2009-10-23 |
| 28691 | SUPPL | 2009-01-06 |
| 16440 | SUPPL | 2009-01-06 |
| 28690 | SUPPL | 2007-10-04 |
| 37743 | SUPPL | 2007-09-26 |
| 42323 | ORIG | 2007-01-22 |
| 6281 | SUPPL | 2006-11-07 |
| 37742 | SUPPL | 2006-11-06 |
| 28689 | SUPPL | 2006-10-02 |
| 28688 | SUPPL | 2006-09-18 |
| 16439 | SUPPL | 2006-09-01 |
| 28687 | ORIG | 2005-08-31 |
| 37741 | ORIG | 2005-08-30 |
| 23077 | ORIG | 2005-08-30 |