Application 202467

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	TABLET;ORAL	EQ 15MG BASE	No	No
002	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	No	No
003	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	TABLET;ORAL	EQ 45MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202467-001	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06
A202467-002	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06
A202467-003	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202467-001	AB
A202467-002	AB
A202467-003	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 4 · 123 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	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202467-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202467-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202467-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A202467-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202467-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202467-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202467-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202467-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202467-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202467-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202467-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202467-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202467-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202467-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202467-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202467-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202467-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202467-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202467-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202467-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202467-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202467-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202467-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202467-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202467-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202467-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202467-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202467-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202467-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202467-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202467-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202467-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202467-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202467-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202467-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202467-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202467-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202467-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202467-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202467-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202467-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202467-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202467-001	AB	1	`8072bd15b7f6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pioglitazone	PIOGLITAZONE	NuCare Pharmaceuticals,Inc.	af863b9e-9646-3b1e-e053-2995a90ab93a	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202467 application number: ANDA202467 ndc (product): 68071-2264
Pioglitazone	PIOGLITAZONE	A-S Medication Solutions	9fe57786-5c7d-4b11-8fb4-de341e2e5128	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202467 application number: ANDA202467
Pioglitazone	PIOGLITAZONE	A-S Medication Solutions	4b5506c4-8cc2-44fb-ba2b-0e29fb73943d	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202467 application number: ANDA202467
Pioglitazone	PIOGLITAZONE	A-S Medication Solutions	475c4f39-dd2a-48f9-a07c-9344bbda58a9	2023-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202467 application number: ANDA202467
Pioglitazone	PIOGLITAZONE	Macleods Pharmaceuticals Limited	482cef76-0623-4b4f-a0ea-f008c97b2281	2022-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202467 application number: ANDA202467 ndc (product): 33342-054 ndc (product): 33342-056 ndc (product): 33342-055
Pioglitazone	PIOGLITAZONE	NorthStar RxLLC	692e662a-3b31-42c3-a075-42abe44c74db	2022-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202467 application number: ANDA202467 ndc (product): 16714-645 ndc (product): 16714-646 ndc (product): 16714-647

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-645	Pioglitazone	Pioglitazone	NorthStar RxLLC	ANDA	Current
16714-645	Pioglitazone	Pioglitazone	NorthStar RxLLC	ANDA	Current
16714-646	Pioglitazone	Pioglitazone	NorthStar RxLLC	ANDA	Current
16714-646	Pioglitazone	Pioglitazone	NorthStar RxLLC	ANDA	Current
16714-647	Pioglitazone	Pioglitazone	NorthStar RxLLC	ANDA	Current
16714-647	Pioglitazone	Pioglitazone	NorthStar RxLLC	ANDA	Current
33342-054	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-054	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-054	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-055	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-055	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-055	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-056	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-056	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
33342-056	Pioglitazone	Pioglitazone	Macleods Pharmaceuticals Limited	ANDA	Current
50090-2637	Pioglitazone	Pioglitazone	A-S Medication Solutions	ANDA	Current
68071-2264	Pioglitazone	Pioglitazone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2264	Pioglitazone	Pioglitazone	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-0088	Pioglitazone	Pioglitazone	Bryant Ranch Prepack	ANDA	Current
71335-0088	Pioglitazone	Pioglitazone	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10056	ORIG	2013-02-08