Application 202726

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEMFIBROZIL	GEMFIBROZIL	TABLET;ORAL	600MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202726-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2015-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202726-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202726-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2015-09-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202726-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202726-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202726-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202726-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202726-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202726-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202726-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202726-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202726-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202726-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202726-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202726-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202726-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202726-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202726-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202726-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202726-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202726-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202726-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202726-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202726-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202726-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202726-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202726-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202726-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202726-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202726-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202726-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202726-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202726-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202726-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202726-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202726-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202726-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202726-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202726-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202726-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202726-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202726-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202726-001	AB	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	16d0326a-a55b-448b-be24-a16182aaef5a	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	efecc680-f626-46bf-bc2b-3b5a72ba0267	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	Bryant Ranch Prepack	e3ef1638-4c2b-4f74-af31-52c081619963	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726 ndc (product): 71335-2025
Gemfibrozil	GEMFIBROZIL	Rising Pharma Holdings, Inc.	8f36abfa-dc52-4c99-8a4a-b0cb80c3249a	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726 ndc (product): 16571-784
Gemfibrozil	GEMFIBROZIL	Aurobindo Pharma Limited	a68f430e-7c98-4bd9-8902-758706713996	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726 ndc (product): 65862-624
Gemfibrozil	GEMFIBROZIL	NorthStar Rx LLC	b5e33ee2-f766-41d6-8a4b-7b4f0e961bf4	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726
Gemfibrozil	GEMFIBROZIL	NCS HealthCare of KY, LLC dba Vangard Labs	394dfb45-cd3c-4e1e-8dd6-7e4867e90a03	2022-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202726 application number: ANDA202726 ndc (product): 0615-8354

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8354	Gemfibrozil	Gemfibrozil	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8354	Gemfibrozil	Gemfibrozil	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
16571-784	Gemfibrozil	Gemfibrozil	Rising Pharma Holdings, Inc.	ANDA	Current
16571-784	Gemfibrozil	Gemfibrozil	Rising Pharma Holdings, Inc.	ANDA	Current
50090-2450	Gemfibrozil	Gemfibrozil	A-S Medication Solutions	ANDA	Current
53002-2068	Gemfibrozil	Gemfibrozil	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2068	Gemfibrozil	Gemfibrozil	RPK Pharmaceuticals, Inc.	ANDA	Current
57237-163	Gemfibrozil	Gemfibrozil	Rising Health, LLC	ANDA	Current
57237-163	Gemfibrozil	Gemfibrozil	Rising Health, LLC	ANDA	Current
57237-163	Gemfibrozil	Gemfibrozil	Rising Health, LLC	ANDA	Current
65862-624	Gemfibrozil	Gemfibrozil	Aurobindo Pharma Limited	ANDA	Current
65862-624	Gemfibrozil	Gemfibrozil	Aurobindo Pharma Limited	ANDA	Current
65862-624	Gemfibrozil	Gemfibrozil	Aurobindo Pharma Limited	ANDA	Current
65862-624	Gemfibrozil	Gemfibrozil	Aurobindo Pharma Limited	ANDA	Current
68071-4631	Gemfibrozil	Gemfibrozil	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-169	Gemfibrozil	Gemfibrozil	Proficient Rx LP	ANDA	Current
71205-169	Gemfibrozil	Gemfibrozil	Proficient Rx LP	ANDA	Current
71335-0899	Gemfibrozil	Gemfibrozil	Bryant Ranch Prepack	ANDA	Current
71335-0899	Gemfibrozil	Gemfibrozil	Bryant Ranch Prepack	ANDA	Current
71335-0899	Gemfibrozil	Gemfibrozil	Bryant Ranch Prepack	ANDA	Current
71335-2025	Gemfibrozil	Gemfibrozil	Bryant Ranch Prepack	ANDA	Current
71335-2025	Gemfibrozil	Gemfibrozil	Bryant Ranch Prepack	ANDA	Current