Application 018657

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLAGYL I.V. RTU 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
N018657-001	FLAGYL I.V. RTU IN PLASTIC CONTAINER	METRONIDAZOLE	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018657-001	AP

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 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	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018657-001	FLAGYL I.V. RTU IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018657-001	FLAGYL I.V. RTU IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018657-001	FLAGYL I.V. RTU IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018657-001	FLAGYL I.V. RTU IN PLASTIC CONTAINER	500MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

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	N018657-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018657-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018657-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018657-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018657-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018657-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018657-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018657-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018657-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018657-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018657-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018657-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018657-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018657-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018657-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018657-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018657-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018657-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018657-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018657-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018657-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018657-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018657-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018657-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018657-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018657-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018657-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018657-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018657-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018657-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018657-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018657-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018657-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018657-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018657-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018657-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018657-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018657-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018657-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018657-001	AP	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Civica, Inc.	902ab25b-d493-495a-884e-96b080e9f72d	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018657 application number: NDA018657
Metronidazole	METRONIDAZOLE	Baxter Healthcare Corporation	d2112f37-5080-4a19-bcc3-6386b49abe1d	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018657 application number: NDA018657 ndc (product): 0338-1055
Metronidazole	METRONIDAZOLE	Baxter Healthcare Corporation	9d762edb-12ac-429d-b1f0-7af5d3b909d4	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018657 application number: NDA018657 ndc (product): 0338-9541

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
0338-1055	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-1055	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-1055	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-1055	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-1055	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-1055	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-9541	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-9541	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-9541	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-9541	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current
0338-9541	Metronidazole	Metronidazole	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82688	SUPPL	2025-06-27
82664	SUPPL	2025-06-25
81617	SUPPL	2025-03-18
81613	SUPPL	2025-03-17
79017	SUPPL	2024-07-09
79004	SUPPL	2024-07-09
69669	SUPPL	2021-12-20
69597	SUPPL	2021-12-16
66698	SUPPL	2021-03-09
66674	SUPPL	2021-03-09
50656	SUPPL	2017-12-12
50619	SUPPL	2017-12-06
33542	SUPPL	2015-07-16
1000	SUPPL	2015-07-14
15072	SUPPL	2013-10-25
11265	SUPPL	2013-10-25
15071	SUPPL	2012-05-30
11264	SUPPL	2011-08-12
999	SUPPL	2011-08-09
998	SUPPL	2009-11-19
11263	SUPPL	2009-09-17
33541	SUPPL	2004-06-07
15070	SUPPL	2004-06-07
11262	SUPPL	2004-06-07
997	SUPPL	2004-06-07