Application 205429

Type: ANDA
Sponsor: ALVOGEN

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
A205429-001	DAPSONE	DAPSONE	25MG	TABLET / ORAL			2016-01-07
A205429-002	DAPSONE	DAPSONE	100MG	TABLET / ORAL			2016-01-07

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205429-001	DAPSONE	25MG	TABLET / ORAL		2016-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205429-002	DAPSONE	100MG	TABLET / ORAL		2016-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205429-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205429-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205429-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205429-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205429-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205429-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205429-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-01-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205429-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205429-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205429-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205429-001	DAPSONE	25MG	TABLET / ORAL	AB	2016-01-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205429-002	DAPSONE	100MG	TABLET / ORAL	AB	2016-01-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205429-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205429-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205429-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205429-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205429-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205429-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205429-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205429-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205429-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205429-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205429-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205429-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205429-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205429-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205429-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205429-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205429-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205429-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205429-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205429-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205429-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205429-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205429-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205429-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205429-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205429-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A205429-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205429-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205429-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205429-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205429-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205429-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205429-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205429-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205429-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205429-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205429-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205429-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205429-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205429-002	AB	1	`3bdfa0b2c4d7…`

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dapsone	DAPSONE	Macleods Pharmaceuticals Limited	839d7440-ba0e-4c56-b648-d374b155cf03	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
DAPSONE	DAPSONE	Alembic Pharmaceuticals Limited	0f1301f6-884d-4fc7-a5b2-421b2375b985	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: DAPSONE generic name: DAPSONE
DAPSONE	DAPSONE	Alembic Pharmaceuticals Inc.	7249f655-1d8e-482a-889a-1e7e1a19500c	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: DAPSONE generic name: DAPSONE
Dapsone	DAPSONE	Sun Pharmaceutical Industries, Inc.	cb312185-b9f1-4fa4-9481-bcf5d9bb3edf	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Viona Pharmaceuticals Inc	58e7b363-99fb-4225-8df1-db2114d74928	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Zydus Lifesciences Limited	1d6bc112-ba2f-40ab-975d-9cfbc853cd11	2026-02-27		Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Rising Pharma Holdings, Inc.	e369b26d-219a-4e23-b8d4-f94048d36acd	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	AvKARE	13002250-b4c5-5890-e063-6394a90a2036	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	AvKARE	459c00e0-2124-8965-e063-6294a90a4278	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE GEL, 5%	Encube Ethicals, Inc.	4205a1a9-c459-47bb-9538-1dd559ca71f1	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Dapsone
Aczone	DAPSONE	Almirall, LLC	22058b7d-a578-4eaa-a476-ac982337f02a	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: DAPSONE
Dapsone	DAPSONE	Alembic Pharmaceuticals Limited	d71eba65-3d78-4252-acb8-90eea60921d1	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE GEL, 5%	Trupharma, LLC	699b6157-3245-43b6-91ee-c86ea262bc83	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Dapsone
Dapsone	DAPSONE	Trupharma, LLC	2763bcbb-e249-be2b-e063-6394a90a5015	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Westminster Pharmaceuticals, LLC	7d317576-5edd-4c27-a00d-68b5944c04a8	2025-08-28	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Westminster Pharmaceuticals, LLC	d3fc4934-d48b-4a29-9022-0c82bbdad399	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	NORTHSTAR RX LLC	91d027f1-cbc6-4066-870b-01b1ddb1f48f	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	NORTHSTAR RX LLC	51ebcb4d-4368-4748-a6f3-1ec2100fed63	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Sun Pharmaceutical Industries, Inc.	32fcb7e0-5a6d-4d95-b81c-148012a54112	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE
Dapsone	DAPSONE	Sun Pharmaceutical Industries, Inc.	97e6444c-1496-4508-9434-8a2a93225e17	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Dapsone generic name: DAPSONE

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
47781-333	Dapsone	dapsone	Alvogen Inc.	ANDA	Current
47781-333	Dapsone	dapsone	Alvogen Inc.	ANDA	Current
47781-333	Dapsone	dapsone	Alvogen Inc.	ANDA	Current
47781-334	Dapsone	dapsone	Alvogen Inc.	ANDA	Current
47781-334	Dapsone	dapsone	Alvogen Inc.	ANDA	Current
47781-334	Dapsone	dapsone	Alvogen Inc.	ANDA	Current