Application 209430

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAPSONE	DAPSONE	TABLET;ORAL	25MG	No	No
002	DAPSONE	DAPSONE	TABLET;ORAL	100MG	No	No

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
A209430-001	DAPSONE	DAPSONE	25MG	TABLET / ORAL			2019-03-01
A209430-002	DAPSONE	DAPSONE	100MG	TABLET / ORAL			2019-03-01

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209430-001	DAPSONE	25MG	TABLET / ORAL	2019-03-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209430-002	DAPSONE	100MG	TABLET / ORAL	2019-03-01	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dapsone	DAPSONE	Sun Pharmaceutical Industries, Inc.	cb312185-b9f1-4fa4-9481-bcf5d9bb3edf	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209430 application number: ANDA209430 ndc (product): 51672-4198 ndc (product): 51672-4197

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4197	Dapsone	Dapsone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4198	Dapsone	Dapsone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current