Application 018422

Type: NDA
Sponsor: PFIZER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPID	GEMFIBROZIL	CAPSULE;ORAL	200MG	No	No
002	LOPID	GEMFIBROZIL	CAPSULE;ORAL	300MG	No	No
003	LOPID	GEMFIBROZIL	TABLET;ORAL	600MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018422-001	LOPID	GEMFIBROZIL	200MG	CAPSULE / ORAL		Approved before 1982
N018422-002	LOPID	GEMFIBROZIL	300MG	CAPSULE / ORAL		Approved before 1982
N018422-003	LOPID	GEMFIBROZIL	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018422-003	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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018422-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018422-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018422-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018422-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018422-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018422-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018422-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018422-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018422-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018422-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018422-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018422-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018422-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018422-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018422-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018422-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018422-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018422-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018422-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018422-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018422-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018422-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018422-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018422-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018422-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018422-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018422-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018422-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018422-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018422-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018422-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018422-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018422-003	AB	1	`3a93d1ddd44b…`

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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	NuCare Pharmaceuticals, Inc.	415ac7e0-ddc7-453e-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Bryant Ranch Prepack	e3ef1638-4c2b-4f74-af31-52c081619963	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Rising Pharma Holdings, Inc.	8f36abfa-dc52-4c99-8a4a-b0cb80c3249a	2024-05-15	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Aurobindo Pharma Limited	a68f430e-7c98-4bd9-8902-758706713996	2024-05-15	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	NorthStar Rx LLC	b5e33ee2-f766-41d6-8a4b-7b4f0e961bf4	2024-05-15	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	17529d33-f24a-1f3f-e063-6394a90ae374	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	5738f713-d4b4-437c-b931-fb3b2c22f6d3	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	4907bbfa-27f4-4569-8957-9704f9c998a0	2023-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Zydus Lifesciences Limited	e6bc1a4f-2a4f-4fdf-8084-488ec8b8b7ab	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Viona Pharmaceuticals Inc	2fc2c8fe-6158-4e4d-9753-dc2be1b10f42	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Bryant Ranch Prepack	fe91d458-1877-4c2e-aa15-efd802e6741f	2023-10-24	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	Bryant Ranch Prepack	54c65a5d-2ff9-493a-90d9-2cff48d1a072	2023-09-15	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Cadila Pharmaceuticals Limited	0b50849a-66b6-4e8f-9f45-5425a875d366	2022-12-27	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	NCS HealthCare of KY, LLC dba Vangard Labs	394dfb45-cd3c-4e1e-8dd6-7e4867e90a03	2022-08-29	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Proficient Rx LP	7dbd38ab-7965-463f-9f8e-70efa8e071fb	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	Aphena Pharma Solutions - Tennessee, LLC	7379a1c1-d34f-4eb8-acb8-c5cbaea0f017	2021-11-01	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	Camber Pharmaceuticals, Inc.	f6a2362a-21e1-442d-9f5d-9e600b5a2ea8	2021-08-26	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
GEMFIBROZIL	GEMFIBROZIL	XLCare Pharmaceuticals, Inc.	58c1f50b-9f84-42fe-b7dd-6eece286e28b	2021-08-26	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Exelan Pharmaceuticals, Inc.	5c09fe54-697e-4cd5-9a26-7c9c7fa9a864	2021-06-21	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL
Gemfibrozil	GEMFIBROZIL	Cipla USA Inc.	05bfbcdc-03ab-4fba-9582-980602410ef9	2021-06-18	Warnings, Adverse reactions	Name fallback generic name: GEMFIBROZIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0071-0737	Lopid	gemfibrozil	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0737	Lopid	gemfibrozil	Parke-Davis Div of Pfizer Inc	NDA	Current
0071-0737	Lopid	gemfibrozil	Parke-Davis Div of Pfizer Inc	NDA	Current
59762-0737	Gemfibrozil	Gemfibrozil	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0737	Gemfibrozil	Gemfibrozil	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0737	Gemfibrozil	Gemfibrozil	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
70518-0687	Lopid	gemfibrozil	REMEDYREPACK INC.	NDA	Current
70518-0687	Lopid	gemfibrozil	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65586	SUPPL	2020-12-14
65574	SUPPL	2020-12-11
53870	SUPPL	2018-04-27
53819	SUPPL	2018-04-26
48067	SUPPL	2017-04-19
48064	SUPPL	2017-04-19
920	SUPPL	2016-04-08
33490	SUPPL	2016-04-07
11218	SUPPL	2014-11-07
919	SUPPL	2014-11-07
15001	SUPPL	2013-11-06
11217	SUPPL	2013-11-01
918	SUPPL	2010-09-29
11216	SUPPL	2010-09-27
11215	SUPPL	2009-07-17
917	SUPPL	2009-07-17
14999	SUPPL	2004-06-08
915	SUPPL	2004-06-08
916	SUPPL	2004-04-07
33489	SUPPL	2003-04-14
11214	SUPPL	2003-04-14
15000	SUPPL	2003-01-15