Application 079072

Type: ANDA
Sponsor: NORTHSTAR HLTHCARE

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 1.

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
A079072-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2010-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079072-001	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 · 41 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	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A079072-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079072-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079072-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079072-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079072-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079072-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079072-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079072-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079072-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079072-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079072-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079072-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079072-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079072-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079072-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079072-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079072-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079072-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079072-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079072-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079072-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079072-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079072-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079072-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079072-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079072-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079072-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079072-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079072-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079072-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079072-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079072-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079072-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079072-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079072-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079072-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079072-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079072-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079072-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079072-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	Northstar RxLLC	75cac02c-56e3-4dfe-b1e2-4ce166b28833	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072 ndc (product): 16714-101
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	5738f713-d4b4-437c-b931-fb3b2c22f6d3	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	4907bbfa-27f4-4569-8957-9704f9c998a0	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-101	Gemfibrozil	gemfibrozil	Northstar RxLLC	ANDA	Current
16714-101	Gemfibrozil	gemfibrozil	Northstar RxLLC	ANDA	Current
68071-2422	Gemfibrozil	gemfibrozil	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-0971	Gemfibrozil	gemfibrozil	Bryant Ranch Prepack	ANDA	Current
71335-0971	Gemfibrozil	gemfibrozil	Bryant Ranch Prepack	ANDA	Current
71335-0971	Gemfibrozil	gemfibrozil	Bryant Ranch Prepack	ANDA	Current