Home Applications 022024 Application 022024
Type NDA
Sponsor TAKEDA PHARMS USA Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table 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.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N022024-001 ACTOPLUS MET XR 1GM;EQ 15MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N022024-002 ACTOPLUS MET XR 1GM;EQ 30MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022024-001 ACTOPLUS MET XR 1GM;EQ 15MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 e64feba35796…2022-09-29 23:25 UTC 2022-09 N022024-002 ACTOPLUS MET XR 1GM;EQ 30MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022024-001 ACTOPLUS MET XR 1GM;EQ 15MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022024-002 ACTOPLUS MET XR 1GM;EQ 30MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022024-001 ACTOPLUS MET XR 1GM;EQ 15MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022024-002 ACTOPLUS MET XR 1GM;EQ 30MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2009-05-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 356 observed states.
Captured, Edition, Application-product table 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 listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table 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