Home Applications 021073 Application 021073
Type NDA
Sponsor TAKEDA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE Yes No 002 ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE Yes No 003 ACTOS PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021073-001 ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 N021073-002 ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 N021073-003 ACTOS PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 1 of 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021073-002 ACTOS EQ 30MG BASE TABLET / ORAL AB RLD 1999-07-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021073-003 ACTOS EQ 45MG BASE TABLET / ORAL AB RLD, RS 1999-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021073-001 ACTOS EQ 15MG BASE TABLET / ORAL AB RLD 1999-07-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-147 Actos pioglitazone hydrochloride Rebel Distributors Corp. NDA Current 21695-148 Actos pioglitazone hydrochloride Rebel Distributors Corp. NDA Current 54458-884 Pioglitazone Pioglitazone International Laboratories, LLC NDA AUTHORIZED GENERIC Current 54458-885 Pioglitazone Pioglitazone International Laboratories, LLC NDA AUTHORIZED GENERIC Current 63304-311 Pioglitazone pioglitazone Ranbaxy Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 63304-312 Pioglitazone pioglitazone Ranbaxy Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 63304-313 Pioglitazone pioglitazone Ranbaxy Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 64764-151 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-151 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-151 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-151 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-301 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-301 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-301 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-301 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-451 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-451 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-451 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 64764-451 Actos pioglitazone Takeda Pharmaceuticals America, Inc. NDA Current 66116-504 Pioglitazone pioglitazone MedVantx, Inc. NDA AUTHORIZED GENERIC Current 68071-1621 Pioglitazone pioglitazone NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 68071-1621 Pioglitazone pioglitazone NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 68071-1621 Pioglitazone pioglitazone NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 68151-3792 Pioglitazone pioglitazone Carilion Materials Management NDA AUTHORIZED GENERIC Current 68151-3798 Pioglitazone pioglitazone Carilion Materials Management NDA AUTHORIZED GENERIC Current 68258-3034 Actos pioglitazone hydrochloride Dispensing Solutions, Inc. NDA Current 68258-5230 Actos pioglitazone hydrochloride Dispensing Solutions, Inc. NDA Current