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 44.

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N012623-001	FLAGYL	METRONIDAZOLE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N012623-003	FLAGYL	METRONIDAZOLE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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 2 of 3 · 88 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
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…`
2022-03-09 01:35 UTC	2022-03	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012623-001	FLAGYL	250MG	TABLET / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012623-003	FLAGYL	500MG	TABLET / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012623-001	FLAGYL	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012623-003	FLAGYL	500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

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 1 of 8 · 142 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	aea4e2a1-2089-40dc-9eee-deaab4f21397	2026-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals, Inc.	4040db14-750f-6d20-e054-00144ff8d46c	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Major Pharmaceuticals	71f5ce2f-17f8-45fc-b27d-2bf982591ab3	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	5cc3fd98-d579-432e-a4b5-b6d5586991a6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	dc28753c-95ec-4b41-ad77-c4a66698d9db	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	b49a8ad0-2cf9-4386-8bf5-1b1df87b0022	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	d5784eeb-6b99-4e8a-847b-b0d1090ed48a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	2f7d84d4-1085-4243-be88-442eecb85205	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Vagizole	METRONIDAZOLE	iNutrition LLC	fd5e884b-cf07-493b-bb93-039bbb0c4784	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	5cf3cc1f-601e-4997-bfb2-a573c31c8189	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	4a233572-2471-4e99-a45e-2de978abcf16	2026-07-15	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5a504f74-bccd-433a-bd5b-6822f98c34df	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5842a554-58d1-4ee4-99aa-1e6029a69be2	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	4748ba37-9d66-497d-aa9f-ca2d541c5f41	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	59e53582-244a-4e9d-b18e-75dddc6a5052	2026-07-08	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	cfeab9e3-58b9-4890-9185-11b62904e2af	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	3e0a14f1-961b-4722-bfea-aafcc5d7706c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	53918705-d2fe-4c6b-9501-a619a8ad3991	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Kanchan Healthcare Inc	8836334e-6db4-44be-bc9e-099b26322cf4	2026-07-01	Boxed warning, Warnings, 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