Application 020785

Type: NDA
Sponsor: CELGENE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THALOMID	THALIDOMIDE	CAPSULE;ORAL	50MG	Yes	No
002	THALOMID	THALIDOMIDE	CAPSULE;ORAL	100MG	Yes	No
003	THALOMID	THALIDOMIDE	CAPSULE;ORAL	200MG	Yes	Yes
004	THALOMID	THALIDOMIDE	CAPSULE;ORAL	150MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020785-001	THALOMID	THALIDOMIDE	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16
N020785-002	THALOMID	THALIDOMIDE	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17
N020785-003	THALOMID	THALIDOMIDE	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17
N020785-004	THALOMID	THALIDOMIDE	150MG	CAPSULE / ORAL		RLD	2007-01-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020785-001	AB
N020785-002	AB
N020785-003	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 5 · 164 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	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020785-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020785-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020785-004	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020785-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020785-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020785-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 426 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020785-001	7230012	2023-12-09		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020785-002	7230012	2023-12-09		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020785-003	7230012	2023-12-09		Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020785-001	7230012	2023-12-09		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020785-002	7230012	2023-12-09		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020785-003	7230012	2023-12-09		Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020785-001	7230012	2023-12-09		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020785-002	7230012	2023-12-09		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020785-003	7230012	2023-12-09		Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6315720	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6315720	2020-10-23	U-442			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6561977	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6561977	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6755784	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6755784	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-733			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-733			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7959566	2020-10-23	U-1155		2011-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	8315886	2020-10-23	U-1249			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	8626531	2020-10-23	U-1465		2014-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7230012	2023-12-09		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6315720	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6315720	2020-10-23	U-442			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6561977	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6561977	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6755784	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6755784	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-733			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	7141018	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	7141018	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	7141018	2020-10-23	U-733			`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thalomid	THALIDOMIDE	Celgene Corporation	2eda833b-1357-4ed4-a093-194524fcb061	2023-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020785 application number: NDA020785 ndc (product): 59572-210 ndc (product): 59572-215 ndc (product): 59572-220 ndc (product): 59572-205

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59572-205	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-205	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-205	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-205	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-205	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-210	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-210	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-210	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-210	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-210	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-215	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-215	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-215	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-215	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-215	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-220	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-220	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-220	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-220	Thalomid	Thalidomide	Celgene Corporation	NDA	Current
59572-220	Thalomid	Thalidomide	Celgene Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85781	SUPPL	2026-05-01
73881	SUPPL	2023-03-27
73880	SUPPL	2023-03-27
73874	SUPPL	2023-03-27
68314	SUPPL	2021-08-06
66436	SUPPL	2021-03-02
66412	SUPPL	2021-03-01
61182	SUPPL	2019-12-06
61181	SUPPL	2019-12-06
61161	SUPPL	2019-12-05
59005	SUPPL	2019-06-10
59004	SUPPL	2019-06-10
59002	SUPPL	2019-06-10
50952	SUPPL	2018-01-02
50951	SUPPL	2018-01-02
50946	SUPPL	2017-12-29
50575	SUPPL	2017-12-01
50539	SUPPL	2017-12-01
48700	SUPPL	2017-06-12
47049	SUPPL	2017-01-31
47031	SUPPL	2017-01-27
25839	SUPPL	2016-04-25
25838	SUPPL	2015-12-02
3355	SUPPL	2015-10-29
3354	SUPPL	2015-09-15
25836	SUPPL	2015-08-10
35357	SUPPL	2015-08-07
25837	SUPPL	2014-09-16
35358	SUPPL	2014-06-23
3353	SUPPL	2014-06-23
3352	SUPPL	2013-11-18
35356	SUPPL	2013-02-12
3351	SUPPL	2013-02-12
25835	SUPPL	2012-02-08
25834	SUPPL	2012-02-08
25833	SUPPL	2012-02-08
35355	SUPPL	2012-02-06
35354	SUPPL	2012-02-06
13437	SUPPL	2012-02-06
23984	ORIG	2010-08-16
3350	SUPPL	2010-08-06
20953	SUPPL	2007-07-27
20952	SUPPL	2007-07-27
25832	SUPPL	2007-01-16
20951	ORIG	2006-09-06
13436	SUPPL	2006-05-26
3349	SUPPL	2006-05-26
25827	SUPPL	2004-06-18
25831	SUPPL	2004-03-10
25830	SUPPL	2004-03-10
44072	ORIG	2003-12-12
35353	SUPPL	2003-10-31
25829	SUPPL	2003-10-31
25828	SUPPL	2003-10-31
13435	SUPPL	2003-10-31
13434	SUPPL	2003-10-31
3348	SUPPL	2003-10-31
35351	SUPPL	2003-04-23
35352	SUPPL	2003-03-06
25826	SUPPL	2003-01-17
13433	SUPPL	2003-01-17
41700	SUPPL	2001-09-05
25825	SUPPL	2001-09-05
13432	SUPPL	2001-09-05
3347	SUPPL	2001-09-05
13431	ORIG	1998-07-16
3346	ORIG	1998-07-16