Application 204380

Type: ANDA
Sponsor: ACTAVIS LLC

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 43.

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
A204380-001	DAPSONE	DAPSONE	25MG	TABLET / ORAL	AB		2017-03-23
A204380-002	DAPSONE	DAPSONE	100MG	TABLET / ORAL	AB		2017-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204380-001	AB
A204380-002	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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204380-001	DAPSONE	25MG	TABLET / ORAL	AB	2017-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204380-002	DAPSONE	100MG	TABLET / ORAL	AB	2017-03-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204380-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204380-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204380-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204380-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204380-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204380-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204380-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204380-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204380-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204380-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204380-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204380-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204380-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204380-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204380-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204380-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204380-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204380-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204380-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204380-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204380-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204380-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204380-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204380-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204380-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204380-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204380-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204380-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204380-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204380-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204380-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204380-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204380-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204380-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204380-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204380-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204380-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204380-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204380-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204380-002	AB	1	`74a2ff9319b5…`

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dapsone	DAPSONE	Mayne Pharma Commercial LLC	cbf9e81e-00ef-4218-975e-6a1610b7f1dd	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
dapsone	DAPSONE	Torrent Pharmaceuticals Limited	f8cffc24-8310-4f21-ae77-7f6ad6095551	2025-06-05	Warnings, Adverse reactions	Name fallback brand name: dapsone generic name: DAPSONE
DAPSONE	DAPSONE	Aurobindo Pharma Limited	acd33f0b-8563-467a-93db-a11902331528	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: DAPSONE generic name: DAPSONE
Dapsone	DAPSONE	Chartwell RX, LLC	93028aff-54f0-4f94-b925-a91400118294	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Alembic Pharmaceuticals Inc.	2811f7de-13bf-45cd-8413-5b04d11f40ff	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
DAPSONE	DAPSONE	ANI Pharmaceuticals, Inc.	57a47368-d1f6-4d61-a2ee-c5f1fe7ff690	2025-02-11	Warnings, Adverse reactions	Name fallback brand name: DAPSONE generic name: DAPSONE
Dapsone	DAPSONE	Coupler LLC	2d018cbb-21b2-5f63-e063-6394a90aadc3	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	20e8ca55-513e-8935-e063-6394a90a11cd	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Mylan Pharmaceuticals Inc.	e04da0a1-d02a-487d-a931-a31034738fdd	2024-05-31	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Viona Pharmaceuticals Inc	30867c69-cf3c-4360-8e56-db96e0b0c3ab	2024-05-11	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Zydus Lifesciences Limited	8b63b653-0507-4f95-9bfa-70fd071e15a6	2024-05-09		Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Proficient Rx LP	9cfe5fe7-abc7-4f48-a597-1b1a5c70a354	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Mayne Pharma	dc495e54-8917-42de-a9fa-1f961bd99d61	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DASPONE	Amneal Pharmaceuticals NY LLC	fba0b181-077a-4667-bde1-cf9592f120c2	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: Dapsone
DAPSONE	DAPSONE	Cosette Pharmaceuticals, Inc.	bc035edf-50d0-47ba-9b60-fe394ab3c32f	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: DAPSONE generic name: DAPSONE
Dapsone	DAPSONE	Amneal Pharmaceuticals LLC	f3e33970-ac11-4bb6-9f39-6f58d86fdefb	2020-05-24	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
DAPSONE	DAPSONE	Pacific Pharma, Inc.	8dbe1a41-6d9d-414f-aa9c-09bd95857e2a	2018-09-30	Warnings, Adverse reactions	Name fallback brand name: DAPSONE generic name: DAPSONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.