Application 214603

Type: ANDA
Sponsor: ASCENT PHARMS INC

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
A214603-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2021-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214603-001	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.

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	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214603-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2021-01-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214603-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214603-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214603-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214603-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214603-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214603-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214603-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214603-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214603-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214603-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214603-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214603-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214603-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214603-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214603-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214603-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214603-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214603-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214603-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214603-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214603-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214603-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214603-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214603-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214603-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214603-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214603-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214603-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214603-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214603-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214603-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214603-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214603-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214603-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214603-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214603-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GEMFIBROZIL	GEMFIBROZIL	Preferred Pharmaceuticals, Inc.	2f5738ac-1c9c-4f3a-8c7d-6039d768831e	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 68788-7964
GEMFIBROZIL	GEMFIBROZIL	NuCare Pharmaceuticals,Inc.	bfddc3bd-c2dc-449e-e053-2a95a90a8adc	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 68071-2387
GEMFIBROZIL	GEMFIBROZIL	A-S Medication Solutions	1967afce-ce55-4b10-bd8c-e4e94130de87	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 50090-5808
GEMFIBROZIL	GEMFIBROZIL	A-S Medication Solutions	929d6a30-ab06-4b43-9147-ab2cc613b41f	2025-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	REMEDYREPACK INC.	42e40524-57e9-4fee-993f-be0fda14936b	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Proficient Rx LP	e52c9c88-8197-48b4-88cb-1b4b22ceaf16	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	fe98f68c-7182-4a88-93a5-cbdbb37fb8c2	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 71335-1996
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	54c65a5d-2ff9-493a-90d9-2cff48d1a072	2023-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603
GEMFIBROZIL	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	7379a1c1-d34f-4eb8-acb8-c5cbaea0f017	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 71610-601
GEMFIBROZIL	GEMFIBROZIL	Camber Pharmaceuticals, Inc.	f6a2362a-21e1-442d-9f5d-9e600b5a2ea8	2021-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 31722-128
GEMFIBROZIL	GEMFIBROZIL	XLCare Pharmaceuticals, Inc.	58c1f50b-9f84-42fe-b7dd-6eece286e28b	2021-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214603 application number: ANDA214603 ndc (product): 72865-186

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-128	GEMFIBROZIL	Gemfibrozil	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-128	GEMFIBROZIL	Gemfibrozil	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-128	GEMFIBROZIL	Gemfibrozil	Camber Pharmaceuticals, Inc.	ANDA	Current
43602-452	GEMFIBROZIL	Gemfibrozil	Ascent Pharmaceuticals, Inc.	ANDA	Current
50090-5808	GEMFIBROZIL	Gemfibrozil	A-S Medication Solutions	ANDA	Current
50090-5808	GEMFIBROZIL	Gemfibrozil	A-S Medication Solutions	ANDA	Current
68071-2387	GEMFIBROZIL	Gemfibrozil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7964	GEMFIBROZIL	Gemfibrozil	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7964	GEMFIBROZIL	Gemfibrozil	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-1996	GEMFIBROZIL	Gemfibrozil	Bryant Ranch Prepack	ANDA	Current
71610-601	GEMFIBROZIL	Gemfibrozil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72865-186	GEMFIBROZIL	Gemfibrozil	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-186	GEMFIBROZIL	Gemfibrozil	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-186	GEMFIBROZIL	Gemfibrozil	XLCare Pharmaceuticals, Inc.	ANDA	Current