Application 012623

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLAGYL	METRONIDAZOLE	TABLET;ORAL	250MG	Yes	No
003	FLAGYL	METRONIDAZOLE	TABLET;ORAL	500MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012623-001	FLAGYL	METRONIDAZOLE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N012623-003	FLAGYL	METRONIDAZOLE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012623-001	FLAGYL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012623-003	FLAGYL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`

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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012623-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012623-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012623-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012623-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012623-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012623-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012623-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012623-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012623-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012623-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012623-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012623-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012623-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012623-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012623-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012623-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012623-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012623-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012623-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012623-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012623-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012623-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012623-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012623-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012623-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012623-003	AB	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012623-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012623-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012623-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012623-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012623-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012623-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012623-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012623-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012623-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012623-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012623-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012623-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012623-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N012623-003	AB	1	`f41ea6bd6efb…`

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 8 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	86da8d86-5ab2-f668-fdfd-b0e93e6a2245	2022-11-21	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	PharmPak, Inc.	be23affb-5b30-40ee-b0b5-829666bafaeb	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	PharmPak, Inc.	6a77b5b6-3199-4526-bd68-2e511353d7c6	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Labs LLC	86415209-5440-41da-abb8-e1a3d5051f91	2022-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Oceanside Pharmaceuticals	cdf2e251-4bbc-4434-9b00-bef6284491e4	2022-06-21	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	AvPAK	9623181f-5e3b-3695-e053-2a95a90a99f6	2022-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Noritate	METRONIDAZOLE	Bausch Health US, LLC	706b09da-6cf9-421d-8e91-f3999474d322	2020-06-01	Adverse reactions	Name fallback generic name: METRONIDAZOLE

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-1821	Flagyl	Metronidazole	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1821	Flagyl	Metronidazole	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1821	Flagyl	Metronidazole	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1821	Flagyl	Metronidazole	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1821	Flagyl	Metronidazole	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1821	Flagyl	Metronidazole	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1821	Flagyl	Metronidazole	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1831	Flagyl	Metronidazole	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1831	Flagyl	Metronidazole	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1831	Flagyl	Metronidazole	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
67296-1802	Flagyl	Metronidazole	RedPharm Drug	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79001	SUPPL	2024-07-09
78997	SUPPL	2024-07-09
75696	SUPPL	2023-10-10
75689	SUPPL	2023-10-10
69667	SUPPL	2021-12-20
69596	SUPPL	2021-12-16
66695	SUPPL	2021-03-09
66676	SUPPL	2021-03-09
53623	SUPPL	2018-04-05
53605	SUPPL	2018-04-04
33092	SUPPL	2015-07-16
12029	SUPPL	2015-07-15
10820	SUPPL	2013-08-21
338	SUPPL	2013-08-20
12028	SUPPL	2010-08-24
33091	SUPPL	2010-08-20
33090	SUPPL	2004-04-05
12027	SUPPL	2004-03-24
10819	SUPPL	2003-05-28
337	SUPPL	2003-05-28