Application 202001

Type: ANDA
Sponsor: TORRENT 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 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
A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB		2013-02-13
A202001-002	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
A202001-001	AB
A202001-002	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 2 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
2022-03-09 01:35 UTC	2022-03	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202001-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202001-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL		2013-02-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202001-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202001-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202001-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202001-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202001-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202001-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202001-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202001-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202001-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202001-002	AB	1	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	A202001-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202001-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A202001-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202001-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202001-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202001-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202001-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202001-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202001-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202001-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202001-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202001-002	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202001-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202001-002	AB	1	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pioglitazone HCL and Metformin HCL	PIOGLITAZONE HCL AND METFORMIN HCL	Torrent Pharmaceuticals Limited	237d8fa2-633c-4c29-84d3-f1b413610dc3	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202001 application number: ANDA202001 ndc (product): 13668-280 ndc (product): 13668-281

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-280	Pioglitazone HCL and Metformin HCL	Pioglitazone HCL and Metformin HCL	Torrent Pharmaceuticals Limited	ANDA	Current
13668-281	Pioglitazone HCL and Metformin HCL	Pioglitazone HCL and Metformin HCL	Torrent Pharmaceuticals Limited	ANDA	Current