Application 200823

Type: ANDA
Sponsor: AUROBINDO PHARMA 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 43.

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
A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB		2013-02-13
A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB		2013-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200823-001	AB
A200823-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200823-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200823-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200823-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200823-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200823-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200823-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200823-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200823-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200823-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200823-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200823-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200823-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200823-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200823-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200823-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200823-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200823-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200823-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200823-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200823-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200823-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200823-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200823-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200823-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200823-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200823-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200823-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200823-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200823-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200823-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200823-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200823-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200823-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200823-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200823-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200823-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200823-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200823-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200823-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200823-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200823-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200823-002	AB	1	`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pioglitazone Hydrochloride and Metformin Hydrochloride	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	1fa2703e-fb73-44d5-aaa2-b12b1090d42c	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200823 application number: ANDA200823 ndc (product): 65862-526 ndc (product): 65862-525
Pioglitazone Hydrochloride and Metformin Hydrochloride	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	8d252dab-e868-42d3-95ea-69423d909e84	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200823 application number: ANDA200823 ndc (product): 57237-217 ndc (product): 57237-218

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-217	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
57237-217	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
57237-217	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
57237-217	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
57237-218	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
57237-218	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
57237-218	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
57237-218	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Rising Health, LLC	ANDA	Current
65862-525	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-525	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-525	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-525	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-526	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-526	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-526	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-526	Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone Hydrochloride and Metformin Hydrochloride	Aurobindo Pharma Limited	ANDA	Current