Application 078599

Type: ANDA
Sponsor: HIKMA PHARMS

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
A078599-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL			2010-08-16

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	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078599-001	GEMFIBROZIL	600MG	TABLET / ORAL		2010-08-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078599-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078599-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078599-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078599-001	AB	1	`ea99ee380514…`

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	REMEDYREPACK INC.	4260d746-bb58-4e10-9ffe-fc414f22b591	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
Lopid	GEMFIBROZIL	Parke-Davis Div of Pfizer Inc	c48855b7-215e-453b-b3b1-a0f9dee7221f	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	Preferred Pharmaceuticals, Inc.	2f5738ac-1c9c-4f3a-8c7d-6039d768831e	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: GEMFIBROZIL generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Coupler LLC	509e6e7c-bb54-f135-e063-6294a90a5279	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Northstar RxLLC	75cac02c-56e3-4dfe-b1e2-4ce166b28833	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	NuCare Pharmaceuticals,Inc.	bfddc3bd-c2dc-449e-e053-2a95a90a8adc	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: GEMFIBROZIL generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Northwind Health Company, LLC	a95264ab-eb86-7699-e053-2995a90a3d1f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	A-S Medication Solutions	1967afce-ce55-4b10-bd8c-e4e94130de87	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: GEMFIBROZIL generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	A-S Medication Solutions	929d6a30-ab06-4b43-9147-ab2cc613b41f	2025-12-06	Warnings, Adverse reactions	Name fallback brand name: GEMFIBROZIL generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	American Health Packaging	4e9e08da-9700-4934-a2b1-4f64c70ea8a2	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	AvPAK	3ebb5947-1fe5-9740-6a4b-1f8b577b2711	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	REMEDYREPACK INC.	42e40524-57e9-4fee-993f-be0fda14936b	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: GEMFIBROZIL generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	PD-Rx Pharmaceuticals, Inc.	5501438d-5247-4f2a-8e15-085276d01725	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	Proficient Rx LP	e52c9c88-8197-48b4-88cb-1b4b22ceaf16	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: GEMFIBROZIL generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	NuCare Pharmaceuticals,Inc.	592811f2-e231-6a58-e053-2991aa0a69a9	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Zydus Pharmaceuticals (USA) Inc.	556945e8-4100-4538-bcba-af5b2f13a7e8	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Chartwell RX, LLC	b8bb442e-66dc-435e-830c-4ba3daa47c04	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	16d0326a-a55b-448b-be24-a16182aaef5a	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	efecc680-f626-46bf-bc2b-3b5a72ba0267	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Gemfibrozil generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	fe98f68c-7182-4a88-93a5-cbdbb37fb8c2	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: GEMFIBROZIL generic name: GEMFIBROZIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9707	Gemfibrozil	Gemfibrozil	West-ward Pharmaceutical Corp	ANDA	Current
59115-094	Gemfibrozil	Gemfibrozil	Hikma Pharmaceutical	ANDA	Current
59115-094	Gemfibrozil	Gemfibrozil	Hikma Pharmaceutical	ANDA	Current