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 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
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.

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
2026-08-01 22:54:32	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N018657-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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