Application 209570

Type: NDA
Sponsor: CHEMO RESEARCH SL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZNIDAZOLE	BENZNIDAZOLE	TABLET;ORAL	12.5MG	Yes	No
002	BENZNIDAZOLE	BENZNIDAZOLE	TABLET;ORAL	100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N209570-001	BENZNIDAZOLE	BENZNIDAZOLE	12.5MG	TABLET / ORAL		RLD	2017-08-29
N209570-002	BENZNIDAZOLE	BENZNIDAZOLE	100MG	TABLET / ORAL		RLD, RS	2017-08-29

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209570-001	BENZNIDAZOLE	12.5MG	TABLET / ORAL	RLD	2017-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209570-002	BENZNIDAZOLE	100MG	TABLET / ORAL	RLD, RS	2017-08-29	`782e0a99824c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-001	ODE-154	2024-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209570-002	ODE-154	2024-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-001	ODE-154	2024-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209570-002	ODE-154	2024-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-001	ODE-154	2024-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209570-002	ODE-154	2024-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-001	ODE-154	2024-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209570-002	ODE-154	2024-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209570-001	ODE-154	2024-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209570-002	ODE-154	2024-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-001	ODE-154	2024-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209570-002	ODE-154	2024-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-001	ODE-154	2024-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209570-002	ODE-154	2024-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-001	ODE-154	2024-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209570-002	ODE-154	2024-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209570-001	ODE-154	2024-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209570-002	ODE-154	2024-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-001	NCE	2022-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-001	ODE-154	2024-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-002	NCE	2022-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209570-002	ODE-154	2024-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209570-001	NCE	2022-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-001	ODE-154	2024-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-002	NCE	2022-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209570-002	ODE-154	2024-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209570-001	NCE	2022-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-001	ODE-154	2024-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-002	NCE	2022-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209570-002	ODE-154	2024-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209570-001	NCE	2022-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-001	ODE-154	2024-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-002	NCE	2022-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209570-002	ODE-154	2024-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209570-001	NCE	2022-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-001	ODE-154	2024-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-002	NCE	2022-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209570-002	ODE-154	2024-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209570-001	NCE	2022-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209570-001	ODE-154	2024-08-29	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benznidazole	BENZNIDAZOLE	Exeltis USA, Inc.	8983d6a0-f63f-4f8e-bba4-38223f39e29b	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209570 application number: NDA209570 ndc (product): 0642-7464 ndc (product): 0642-7463

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0642-7463	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7463	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7463	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7463	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7463	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7463	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7464	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7464	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7464	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7464	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7464	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current
0642-7464	Benznidazole	benznidazole	Exeltis USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69704	SUPPL	2021-12-21
69613	SUPPL	2021-12-17
60804	SUPPL	2019-11-12
49990	ORIG	2017-10-10
49610	ORIG	2017-08-30
49609	ORIG	2017-08-30