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 44.

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020785-001	THALOMID	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-002	THALOMID	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-003	THALOMID	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020785-001	THALOMID	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-002	THALOMID	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-003	THALOMID	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020785-001	THALOMID	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-002	THALOMID	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-003	THALOMID	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020785-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020785-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020785-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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