Application 203916

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DISULFIRAM	DISULFIRAM	TABLET;ORAL	250MG	No	No
002	DISULFIRAM	DISULFIRAM	TABLET;ORAL	500MG	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
A203916-001	DISULFIRAM	DISULFIRAM	250MG	TABLET / ORAL			2015-03-04
A203916-002	DISULFIRAM	DISULFIRAM	500MG	TABLET / ORAL			2015-03-04

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	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203916-001	DISULFIRAM	250MG	TABLET / ORAL	2015-03-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203916-002	DISULFIRAM	500MG	TABLET / ORAL	2015-03-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A203916-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203916-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203916-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203916-002	AB	1	`ea99ee380514…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Disulfiram	DISULFIRAM	Golden State Medical Supply, Inc.	d3832a1a-a140-49c1-a7df-134fa81341e3	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Disulfiram generic name: DISULFIRAM
Disulfiram	DISULFIRAM	Alvogen Inc.	b90f8ff4-4fb3-46ab-8149-cb55f24a4044	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Disulfiram generic name: DISULFIRAM
Disulfiram	DISULFIRAM	Bryant Ranch Prepack	bd09ba63-7eef-4740-b5e9-383887024f1f	2025-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Disulfiram generic name: DISULFIRAM
Disulfiram	DISULFIRAM	Sigmapharm Laboratories, LLC	40f5497f-fe84-43b2-8ff4-32d59edf3917	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Disulfiram generic name: DISULFIRAM
Disulfiram	DISULFIRAM	Chartwell RX, LLC	07abe950-3565-418c-8086-b804406a8c87	2023-10-05	Warnings, Adverse reactions	Name fallback brand name: Disulfiram generic name: DISULFIRAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4140	Disulfiram	disulfiram	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4140	Disulfiram	disulfiram	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4141	Disulfiram	disulfiram	Mylan Pharmaceuticals Inc	ANDA	Current
0378-4141	Disulfiram	disulfiram	Mylan Pharmaceuticals Inc.	ANDA	Current