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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022024-001 | ACTOPLUS MET XR | 1GM;EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022024-002 | ACTOPLUS MET XR | 1GM;EQ 30MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2009-05-12 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N022024-001 | 7785627 | 2026-07-31 | Drug product | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N022024-001 | 7959946 | 2026-07-31 | Drug product | 2011-06-30 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022024-002 | 7785627 | 2026-07-31 | Drug product | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N022024-002 | 7959946 | 2026-07-31 | Drug product | c2088c7a36db… | ||
| 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… |
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 |