Application 204651

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METRONIDAZOLE	METRONIDAZOLE	GEL;TOPICAL	1%	No	No

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
A204651-001	METRONIDAZOLE	METRONIDAZOLE	1%	GEL / TOPICAL	AB		2017-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204651-001	AB

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	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB		2017-03-14	`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	A204651-001	AB	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5a504f74-bccd-433a-bd5b-6822f98c34df	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204651 application number: ANDA204651 ndc (product): 51672-4164
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5842a554-58d1-4ee4-99aa-1e6029a69be2	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204651 application number: ANDA204651 ndc (product): 51672-4215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4164	Metronidazole	Metronidazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4164	Metronidazole	Metronidazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4164	Metronidazole	Metronidazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4215	Metronidazole	Metronidazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4215	Metronidazole	Metronidazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4215	Metronidazole	Metronidazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current