Application 076801

Type: ANDA
Sponsor: MYLAN PHARMS INC

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 43.

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	Approval date
A076801-001	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2012-08-17
A076801-002	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	2012-08-17
A076801-003	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2012-08-17

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 2 of 4 · 129 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
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL		2012-08-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		2012-08-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076801-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL		2012-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076801-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2012-08-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076801-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2012-08-17	`3f01610625f2…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076801-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076801-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076801-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076801-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076801-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076801-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076801-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076801-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076801-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076801-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076801-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076801-003	AB	1	`ea99ee380514…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	GSMS, Incorporated	d740d2a2-b26d-4b16-aedc-e4b4b1c94daa	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	6cd7c8b7-f5d4-423b-ae9f-86541869d8cf	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	e64b46e5-3c94-4635-908e-cdc2263bd3d4	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	41a9586c-8768-4fc3-bb78-e6d98b09030b	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	29073b0a-1d7e-4354-87c7-e764106978d8	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	Chartwell RX, LLC	699e865a-952e-459e-a871-9b7cce475b71	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	Bryant Ranch Prepack	c9548800-4c44-473d-a89b-c705484548b3	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	Aurobindo Pharma Limited	1f259863-21fd-4d62-b094-4eff845944df	2025-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	0331400c-b163-4856-bfb0-965470247cb3	2025-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	31619517-a590-408a-ae9e-76c99f0a0a1d	2025-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIOGLITAZONE HYDROCHLORIDE generic name: PIOGLITAZONE HYDROCHLORIDE

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0048	Pioglitazone	pioglitazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0048	Pioglitazone	pioglitazone	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0228	Pioglitazone	pioglitazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0228	Pioglitazone	pioglitazone	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0318	Pioglitazone	pioglitazone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0318	Pioglitazone	pioglitazone	Mylan Pharmaceuticals Inc	ANDA	Current
51079-513	Pioglitazone	pioglitazone	Mylan Institutional Inc.	ANDA	Current
51079-514	Pioglitazone	pioglitazone	Mylan Institutional Inc.	ANDA	Current
51079-515	Pioglitazone	pioglitazone	Mylan Institutional Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8966	ORIG	2012-08-21
44322	ORIG	2009-11-12