Application 018900

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METRO I.V. IN PLASTIC CONTAINER	METRONIDAZOLE	INJECTABLE;INJECTION	500MG/100ML	Yes	Yes

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

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
N018900-001	METRO I.V. IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE / INJECTION		RLD	1983-09-29

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 · 44 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	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION		RLD	1983-09-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION		RLD	1983-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION		RLD	1983-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION		RLD	1983-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018900-001	METRO I.V. IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1983-09-29	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018900-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018900-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018900-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018900-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018900-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018900-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018900-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018900-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018900-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018900-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018900-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018900-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018900-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018900-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018900-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018900-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018900-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018900-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018900-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018900-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018900-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018900-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018900-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018900-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018900-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018900-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018900-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018900-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018900-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018900-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018900-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018900-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018900-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018900-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018900-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018900-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018900-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018900-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018900-001	AP	1	`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 7 of 7 · 140 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c2dbfec8-da5b-cd2b-e053-2a95a90ad17c	2024-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	de4cb39f-cc6e-98fb-05e5-103f3aca2dad	2023-11-29	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Nuvessa	METRONIDAZOLE	Exeltis USA, Inc.	3b6ff39d-f84b-43b3-9b07-c0521c6d7968	2023-11-10	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	8b2c294b-ed70-447c-bbc4-2a8b59f1aca4	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole vaginal	METRONIDAZOLE	Padagis Israel Pharmaceuticals Ltd	eb240e7b-cec8-497b-8a49-7ed768e2b431	2023-07-25	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	d76810d5-11b4-4b5e-b850-230f59376c34	2023-07-18	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Zydus Lifesciences Limited	728ebe6d-7a20-481d-845a-ceffa450179f	2023-05-05		Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	bff2f5bd-75a4-4252-a643-c21741ae8a96	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	a0d7d4e8-28c0-4211-8d76-73a173b48d9a	2023-01-31	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	80c79325-1ea4-46f8-b9b8-967b7640c51d	2023-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	d7455566-16aa-488a-af2a-93b55a04c02f	2023-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	387053e5-7eda-4282-b58a-5789430a2e99	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Proficient Rx LP	205054e1-8172-47dc-931c-a18a60e7e9f0	2022-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-5535	METRONIDAZOLE	METRONIDAZOLE	B. Braun Medical Inc.	NDA	Current
0264-5535	METRONIDAZOLE	METRONIDAZOLE	B. Braun Medical Inc.	NDA	Current
0264-5535	METRONIDAZOLE	METRONIDAZOLE	B. Braun Medical Inc.	NDA	Current
0264-5535	METRONIDAZOLE	METRONIDAZOLE	B. Braun Medical Inc.	NDA	Current
55154-5175	METRONIDAZOLE	METRONIDAZOLE	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85754	SUPPL	2026-04-27
85743	SUPPL	2026-04-24
81619	SUPPL	2025-03-18
81612	SUPPL	2025-03-17
79020	SUPPL	2024-07-09
79007	SUPPL	2024-07-09
69673	SUPPL	2021-12-20
69606	SUPPL	2021-12-17
67305	SUPPL	2021-04-30
67263	SUPPL	2021-04-30
66693	SUPPL	2021-03-09
66668	SUPPL	2021-03-09
53687	SUPPL	2018-04-16
53662	SUPPL	2018-04-12
33638	SUPPL	2015-12-10
1123	SUPPL	2015-12-10
33639	SUPPL	2015-07-16
1124	SUPPL	2015-07-14