Application 020868

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLAGYL ER	METRONIDAZOLE	TABLET, EXTENDED RELEASE;ORAL	750MG	Yes	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
N020868-001	FLAGYL ER	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL		RLD	1997-11-26

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020868-001	FLAGYL ER	750MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1997-11-26	`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 3 of 8 · 150 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metronidazole vaginal	METRONIDAZOLE	REMEDYREPACK INC.	b07f42dd-75d4-499a-984f-c06894ff3a45	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Sportpharm LLC	dc8e448e-ac4e-4efc-8851-c368e31b9d69	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Fougera Pharmaceuticals, LLC	43ed872b-63ac-4a22-9c9e-cc0e05bcc41e	2026-01-28	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Fougera Pharmaceuticals, LLC	5368755a-dd37-4e34-843f-ece6bac8ef6a	2026-01-28	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	1a28dce0-07af-401a-a6ac-1c2ee559c668	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	ab695a3e-1721-491a-97a2-c3f617a8d9fc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	9ed89bfc-ccf3-4e6c-924f-2a14bf82163f	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	GLENMARK PHARMACEUTICALS INC., USA	6736c100-a7fe-44ea-8579-5537537ff9b8	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	Direct_Rx	90a5acb3-f8cc-1e82-e053-2995a90a4e97	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	American Health Packaging	c90da73c-e48e-411a-bd75-0b107f1141cc	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Solaris Pharma Corporation	94a83daa-6e34-419d-849a-6f18d3b8c586	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	06bd4afb-4a45-294c-e063-6394a90a7ab1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f2f55405-7f21-3ccc-e053-2a95a90a195a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f7e5dacd-0bc4-4ac4-e053-6394a90a457a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Proficient Rx LP	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Redpharm Drug	300b51d0-8fca-24ef-e063-6294a90ad2b9	2025-12-23	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals, Inc.	4040db14-750f-6d20-e054-00144ff8d46c	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Redpharm Drug	32523df9-8c47-200f-e063-6294a90ac890	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Chartwell RX, LLC	40509b3c-b725-400c-abe5-d6d5714d405d	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	60ad086d-6f54-4134-b608-53a6ff571ff8	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79025	SUPPL	2024-07-09
79010	SUPPL	2024-07-09
75699	SUPPL	2023-10-10
75686	SUPPL	2023-10-10
69678	SUPPL	2021-12-20
69611	SUPPL	2021-12-17
66690	SUPPL	2021-03-09
66665	SUPPL	2021-03-09
53625	SUPPL	2018-04-05
53603	SUPPL	2018-04-04
35538	SUPPL	2015-07-16
26085	SUPPL	2015-07-14
35537	SUPPL	2013-08-21
26084	SUPPL	2013-08-20
3618	SUPPL	2010-08-24
13647	SUPPL	2010-08-20
35536	SUPPL	2004-04-05
26083	SUPPL	2004-03-24
3617	SUPPL	2003-05-29
13646	SUPPL	2003-04-28
21033	ORIG	1997-11-26