Application 021880

Type: NDA
Sponsor: CELGENE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	5MG	Yes	No
002	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	10MG	Yes	No
003	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	15MG	Yes	No
004	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	25MG	Yes	Yes
005	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	2.5MG	Yes	No
006	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	20MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021880-001	REVLIMID	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27
N021880-002	REVLIMID	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27
N021880-003	REVLIMID	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29
N021880-004	REVLIMID	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29
N021880-005	REVLIMID	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	RLD	2011-12-21
N021880-006	REVLIMID	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	RLD	2013-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021880-001	AB
N021880-002	AB
N021880-003	AB
N021880-004	AB
N021880-005	AB
N021880-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021880-001	7465800	2027-04-27		Drug substance, Drug product
N021880-001	8741929	2028-03-08	U-1983		2014-06-17
N021880-002	7465800	2027-04-27		Drug substance, Drug product
N021880-002	8741929	2028-03-08	U-1983		2014-06-17
N021880-003	7465800	2027-04-27		Drug substance, Drug product
N021880-003	8741929	2028-03-08	U-1983		2014-06-17
N021880-004	7465800	2027-04-27		Drug substance, Drug product
N021880-004	8741929	2028-03-08	U-1983		2014-06-17
N021880-005	7465800	2027-04-27		Drug substance, Drug product	2012-01-17
N021880-005	8741929	2028-03-08	U-1983		2014-06-17
N021880-006	7465800	2027-04-27		Drug substance, Drug product
N021880-006	8741929	2028-03-08	U-1983		2014-06-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N021880-001	ODE-241	2026-05-28
N021880-001	ODE-245	2026-05-28
N021880-002	ODE-241	2026-05-28
N021880-002	ODE-245	2026-05-28
N021880-003	ODE-241	2026-05-28
N021880-003	ODE-245	2026-05-28
N021880-004	ODE-241	2026-05-28
N021880-004	ODE-245	2026-05-28
N021880-005	ODE-241	2026-05-28
N021880-005	ODE-245	2026-05-28
N021880-006	ODE-241	2026-05-28
N021880-006	ODE-245	2026-05-28

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 7 · 264 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	N021880-001	REVLIMID	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-002	REVLIMID	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-003	REVLIMID	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-004	REVLIMID	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-005	REVLIMID	2.5MG	CAPSULE / ORAL	AB	RLD	2011-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-006	REVLIMID	20MG	CAPSULE / ORAL	AB	RLD	2013-06-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021880-001	REVLIMID	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-002	REVLIMID	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-003	REVLIMID	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-004	REVLIMID	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-005	REVLIMID	2.5MG	CAPSULE / ORAL	AB	RLD	2011-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-006	REVLIMID	20MG	CAPSULE / ORAL	AB	RLD	2013-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021880-001	REVLIMID	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-002	REVLIMID	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-003	REVLIMID	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-004	REVLIMID	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-005	REVLIMID	2.5MG	CAPSULE / ORAL	AB	RLD	2011-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-006	REVLIMID	20MG	CAPSULE / ORAL	AB	RLD	2013-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021880-001	REVLIMID	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-002	REVLIMID	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-003	REVLIMID	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-004	REVLIMID	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-005	REVLIMID	2.5MG	CAPSULE / ORAL	AB	RLD	2011-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-006	REVLIMID	20MG	CAPSULE / ORAL	AB	RLD	2013-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-001	REVLIMID	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-002	REVLIMID	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-003	REVLIMID	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-004	REVLIMID	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-005	REVLIMID	2.5MG	CAPSULE / ORAL	AB	RLD	2011-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-006	REVLIMID	20MG	CAPSULE / ORAL	AB	RLD	2013-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021880-001	REVLIMID	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-002	REVLIMID	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-003	REVLIMID	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-004	REVLIMID	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-005	REVLIMID	2.5MG	CAPSULE / ORAL	AB	RLD	2011-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-006	REVLIMID	20MG	CAPSULE / ORAL	AB	RLD	2013-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-001	REVLIMID	5MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-002	REVLIMID	10MG	CAPSULE / ORAL	AB	RLD	2005-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-003	REVLIMID	15MG	CAPSULE / ORAL	AB	RLD	2006-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-004	REVLIMID	25MG	CAPSULE / ORAL	AB	RLD, RS	2006-06-29	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 216 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021880-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021880-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021880-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021880-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021880-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021880-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021880-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021880-004	AB	1	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 4 of 74 · 2,958 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-003	7855217	2024-11-24		Drug substance, Drug product	2012-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-003	7465800	2027-04-27		Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-003	8741929	2028-03-08	U-1983		2014-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-004	7855217	2024-11-24		Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-004	7465800	2027-04-27		Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-004	8741929	2028-03-08	U-1983		2014-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-005	7855217	2024-11-24		Drug substance, Drug product	2012-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-005	7465800	2027-04-27		Drug substance, Drug product	2012-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-005	8741929	2028-03-08	U-1983		2014-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-006	7855217	2024-11-24		Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-006	7465800	2027-04-27		Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021880-006	8741929	2028-03-08	U-1983		2014-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-001	7855217	2024-11-24		Drug substance, Drug product	2011-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-001	7465800	2027-04-27		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-001	8741929	2028-03-08	U-1983		2014-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-002	7855217	2024-11-24		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-002	7465800	2027-04-27		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-002	8741929	2028-03-08	U-1983		2014-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-003	7855217	2024-11-24		Drug substance, Drug product	2012-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-003	7465800	2027-04-27		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-003	8741929	2028-03-08	U-1983		2014-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-004	7855217	2024-11-24		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-004	7465800	2027-04-27		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-004	8741929	2028-03-08	U-1983		2014-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-005	7855217	2024-11-24		Drug substance, Drug product	2012-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-005	7465800	2027-04-27		Drug substance, Drug product	2012-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-005	8741929	2028-03-08	U-1983		2014-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-006	7855217	2024-11-24		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-006	7465800	2027-04-27		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021880-006	8741929	2028-03-08	U-1983		2014-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-001	7855217	2024-11-24		Drug substance, Drug product	2011-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-001	7465800	2027-04-27		Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-001	8741929	2028-03-08	U-1983		2014-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-002	7855217	2024-11-24		Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-002	7465800	2027-04-27		Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-002	8741929	2028-03-08	U-1983		2014-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-003	7855217	2024-11-24		Drug substance, Drug product	2012-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-003	7465800	2027-04-27		Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-003	8741929	2028-03-08	U-1983		2014-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021880-004	7855217	2024-11-24		Drug substance, Drug product		`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 28 · 1,098 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N021880-001	ODE-241	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-001	ODE-245	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-002	ODE-241	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-002	ODE-245	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-003	ODE-241	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-003	ODE-245	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-004	ODE-241	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-004	ODE-245	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-005	ODE-241	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-005	ODE-245	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-006	ODE-241	2026-05-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021880-006	ODE-245	2026-05-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021880-001	ODE-241	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-001	ODE-245	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-002	ODE-241	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-002	ODE-245	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-003	ODE-241	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-003	ODE-245	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-004	ODE-241	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-004	ODE-245	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-005	ODE-241	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-005	ODE-245	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-006	ODE-241	2026-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021880-006	ODE-245	2026-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021880-001	ODE-241	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-001	ODE-245	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-002	ODE-241	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-002	ODE-245	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-003	ODE-241	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-003	ODE-245	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-004	ODE-241	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-004	ODE-245	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-005	ODE-241	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-005	ODE-245	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-006	ODE-241	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021880-006	ODE-245	2026-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021880-001	ODE-241	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-001	ODE-245	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-002	ODE-241	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021880-002	ODE-245	2026-05-28	`011fe1cb6892…`

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
Revlimid	LENALIDOMIDE	Celgene Corporation	5fa97bf5-28a2-48f1-8955-f56012d296be	2023-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021880 application number: NDA021880 ndc (product): 59572-405 ndc (product): 59572-410 ndc (product): 59572-420 ndc (product): 59572-402 ndc (product): 59572-425 ndc (product): 59572-415

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 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85783	SUPPL	2026-05-01
76518	ORIG	2023-11-07
73879	SUPPL	2023-03-27
73878	SUPPL	2023-03-27
73868	SUPPL	2023-03-27
71144	SUPPL	2022-05-25
71143	SUPPL	2022-05-25
71142	SUPPL	2022-05-25
68545	SUPPL	2021-09-07
68544	SUPPL	2021-09-07
68509	SUPPL	2021-09-01
68320	SUPPL	2021-08-09
64676	SUPPL	2020-09-25
60758	SUPPL	2019-10-31
60757	SUPPL	2019-10-31
60750	SUPPL	2019-10-31
58964	SUPPL	2019-06-04
58865	SUPPL	2019-05-28
58864	SUPPL	2019-05-28
57522	SUPPL	2019-02-13
57329	SUPPL	2019-01-23
57328	SUPPL	2019-01-23
50954	SUPPL	2018-01-02
50953	SUPPL	2018-01-02
50947	SUPPL	2017-12-29
50573	SUPPL	2017-12-01
50572	SUPPL	2017-12-01
50544	SUPPL	2017-11-30
50543	SUPPL	2017-11-30
49787	SUPPL	2017-09-19
49773	SUPPL	2017-09-18
48868	SUPPL	2017-06-29
47298	SUPPL	2017-02-23
47289	SUPPL	2017-02-22
6373	SUPPL	2016-04-26
28771	SUPPL	2015-12-02
6372	SUPPL	2015-10-29
6371	SUPPL	2015-09-15
16515	SUPPL	2015-02-24
28770	SUPPL	2015-02-19
37814	SUPPL	2014-09-19
16514	SUPPL	2014-09-19
28769	SUPPL	2014-09-16
6370	SUPPL	2014-09-16
6368	SUPPL	2013-11-18
6369	SUPPL	2013-11-07
37813	SUPPL	2013-11-04
28768	SUPPL	2013-06-06
37812	SUPPL	2013-06-05
37811	SUPPL	2013-02-12
28767	SUPPL	2013-02-12
16513	SUPPL	2013-02-12
6367	SUPPL	2013-02-12
28766	SUPPL	2012-05-11
37810	SUPPL	2012-05-10
6366	SUPPL	2012-03-14
37809	SUPPL	2012-03-12
6365	SUPPL	2011-12-28
16512	SUPPL	2011-12-23
28765	SUPPL	2010-10-19
16511	SUPPL	2010-10-19
24011	ORIG	2010-08-16
16509	SUPPL	2010-08-10
6363	SUPPL	2010-08-09
28764	SUPPL	2009-03-03
28763	SUPPL	2009-03-03
6364	SUPPL	2009-03-03
37808	SUPPL	2009-02-24
37807	SUPPL	2009-02-24
16510	SUPPL	2009-02-24
28762	SUPPL	2006-07-13
37806	SUPPL	2006-07-03
21855	ORIG	2006-02-08
28761	ORIG	2006-01-06
37805	ORIG	2005-12-28
23682	ORIG	2005-12-28