Application 022024
- Type
- NDA
- Sponsor
- TAKEDA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 15MG BASE | Yes | No |
| 002 | ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 30MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022024-001 | ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | |
| N022024-002 | ACTOPLUS MET XR | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022024-001 | 7785627 | 2026-07-31 | Drug product | ||
| N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | |
| N022024-002 | 7785627 | 2026-07-31 | Drug product | ||
| N022024-002 | 7959946 | 2026-07-31 | Drug product |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 74a2ff9319b5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022024-001 | 7785627 | 2026-07-31 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022024-002 | 7785627 | 2026-07-31 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022024-002 | 7959946 | 2026-07-31 | Drug product | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022024-001 | 7785627 | 2026-07-31 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022024-002 | 7785627 | 2026-07-31 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022024-002 | 7959946 | 2026-07-31 | Drug product | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022024-001 | 7785627 | 2026-07-31 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022024-002 | 7785627 | 2026-07-31 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022024-002 | 7959946 | 2026-07-31 | Drug product | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022024-001 | 7785627 | 2026-07-31 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022024-002 | 7785627 | 2026-07-31 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022024-002 | 7959946 | 2026-07-31 | Drug product | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022024-001 | 7785627 | 2026-07-31 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022024-002 | 7785627 | 2026-07-31 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022024-002 | 7959946 | 2026-07-31 | Drug product | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022024-001 | 7785627 | 2026-07-31 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022024-002 | 7785627 | 2026-07-31 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022024-002 | 7959946 | 2026-07-31 | Drug product | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022024-001 | 7785627 | 2026-07-31 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022024-002 | 7785627 | 2026-07-31 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022024-002 | 7959946 | 2026-07-31 | Drug product | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022024-001 | 7785627 | 2026-07-31 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022024-002 | 7785627 | 2026-07-31 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022024-002 | 7959946 | 2026-07-31 | Drug product | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022024-001 | 7785627 | 2026-07-31 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022024-002 | 7785627 | 2026-07-31 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022024-002 | 7959946 | 2026-07-31 | Drug product | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022024-001 | 7785627 | 2026-07-31 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022024-002 | 7785627 | 2026-07-31 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022024-002 | 7959946 | 2026-07-31 | Drug product | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64764-310 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-310 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-310 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-510 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-510 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-510 | Actoplus Met | pioglitazone and metformin hydrochloride | Takeda Pharmaceuticals America, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50919 | SUPPL | 2017-12-27 |
| 50858 | SUPPL | 2017-12-26 |
| 50857 | SUPPL | 2017-12-26 |
| 46190 | SUPPL | 2016-12-15 |
| 46144 | SUPPL | 2016-12-14 |
| 46139 | SUPPL | 2016-12-13 |
| 16788 | SUPPL | 2013-11-14 |
| 6710 | SUPPL | 2013-11-14 |
| 6713 | SUPPL | 2012-05-22 |
| 38101 | SUPPL | 2011-08-04 |
| 29097 | SUPPL | 2011-08-04 |
| 16790 | SUPPL | 2011-08-04 |
| 6712 | SUPPL | 2011-08-04 |
| 6711 | SUPPL | 2010-12-28 |
| 16789 | SUPPL | 2010-12-26 |
| 21911 | ORIG | 2010-03-25 |
| 23692 | ORIG | 2009-11-12 |
| 38100 | ORIG | 2009-07-08 |
| 6709 | ORIG | 2009-05-14 |