Application 204802

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	TABLET;ORAL	500MG;EQ 15MG BASE	No	No
002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	TABLET;ORAL	850MG;EQ 15MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB		2015-11-05
A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB		2015-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204802-001	AB
A204802-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204802-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204802-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204802-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204802-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204802-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204802-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204802-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204802-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204802-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204802-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204802-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204802-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204802-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204802-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204802-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204802-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204802-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204802-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204802-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204802-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204802-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204802-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204802-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204802-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204802-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204802-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204802-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204802-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204802-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204802-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204802-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204802-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204802-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204802-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204802-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204802-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pioglitazone and metformin hydrochloride	PIOGLITAZONE AND METFORMIN HYDROCHLORIDE	Macleods Pharmaceuticals Limited	5ff2cd9e-a579-48f5-845f-c37a68372a34	2026-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204802 application number: ANDA204802 ndc (product): 33342-177 ndc (product): 33342-176
Pioglitazone and metformin hydrochloride	PIOGLITAZONE AND METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	86ca843a-441b-488d-be1d-2576aeee19cf	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204802 application number: ANDA204802
Pioglitazone and metformin hydrochloride	PIOGLITAZONE AND METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	8080eedb-e955-4059-98b2-9685b608eb3e	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204802 application number: ANDA204802
Pioglitazole and metformin hydrochloride	PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	7418254e-7232-466f-9d6b-4743b0bba2a1	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204802 application number: ANDA204802
Pioglitazole and metformin hydrochloride	PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	bd9c05c9-278f-498d-881c-29ba1b60596e	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204802 application number: ANDA204802

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-176	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-176	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-176	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-176	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-177	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-177	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-177	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-177	Pioglitazole and metformin hydrochloride	Pioglitazole and metformin hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32594	ORIG	2015-11-09