Application 078012

Type: ANDA
Sponsor: CARIBE HOLDINGS

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
A078012-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2007-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078012-001	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	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078012-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2007-03-26	`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	A078012-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078012-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078012-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078012-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078012-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078012-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078012-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078012-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078012-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078012-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078012-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078012-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078012-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078012-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078012-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078012-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078012-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078012-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078012-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078012-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078012-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078012-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078012-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078012-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078012-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078012-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078012-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078012-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078012-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078012-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078012-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078012-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078012-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078012-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078012-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078012-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078012-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078012-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078012-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078012-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	2cb2de4d-8261-46d8-ae63-c572fdc887d4	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078012 application number: ANDA078012 ndc (product): 71335-0051
Gemfibrozil	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	17529d33-f24a-1f3f-e063-6394a90ae374	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078012 application number: ANDA078012

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
24658-260	Gemfibrozil	Gemfibrozil	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
24658-260	Gemfibrozil	Gemfibrozil	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
42806-260	GEMFIBROZIL	GEMFIBROZIL	Epic Pharma, LLC	ANDA	Current
42806-260	GEMFIBROZIL	GEMFIBROZIL	Epic Pharma, LLC	ANDA	Current
42806-260	GEMFIBROZIL	GEMFIBROZIL	Epic Pharma, LLC	ANDA	Current
43063-921	GEMFIBROZIL	GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-921	GEMFIBROZIL	GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-921	GEMFIBROZIL	GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-921	GEMFIBROZIL	GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-921	GEMFIBROZIL	GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-772	Gemfibrozil	Gemfibrozil	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
51013-811	GEMFIBROZIL	GEMFIBROZIL	PuraCap Pharmaceutical, LLC	ANDA	Current
53808-0863	Gemfibrozil	Gemfibrozil	State of Florida DOH Central Pharmacy	ANDA	Current
60760-260	GEMFIBROZIL	GEMFIBROZIL	St. Mary's Medical Park Pharmacy	ANDA	Current
71335-0051	GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	ANDA	Current
71335-0051	GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	ANDA	Current