Application 210435

Type: ANDA
Sponsor: CIPLA

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210435-001	LENALIDOMIDE	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06
A210435-002	LENALIDOMIDE	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06
A210435-003	LENALIDOMIDE	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06
A210435-004	LENALIDOMIDE	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06
A210435-005	LENALIDOMIDE	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A210435-001	AB
A210435-002	AB
A210435-003	AB
A210435-004	AB
A210435-005	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 4 · 131 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	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2022-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2022-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2022-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-004	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2022-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2023-03-06	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210435-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210435-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210435-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210435-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210435-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210435-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210435-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210435-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210435-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210435-005	AB	1	`5bbf6a4d5a75…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lenalidomide	LENALIDOMIDE	Cipla USA Inc.	ba2a07fd-ca60-40bc-b79b-9caf81900fa3	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210435 application number: ANDA210435 ndc (product): 69097-383 ndc (product): 69097-381 ndc (product): 69097-385 ndc (product): 69097-382
lenalidomide	LENALIDOMIDE	EXELAN PHARMACEUTICALS INC.	682e8a86-9f49-45db-a2ea-403ee1dc62d2	2024-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210435 application number: ANDA210435 ndc (product): 76282-698 ndc (product): 76282-701 ndc (product): 76282-699 ndc (product): 76282-697

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-381	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
69097-382	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
69097-383	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
69097-385	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
76282-697	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-697	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-698	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-698	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-699	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-699	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-701	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-701	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76344	ORIG	2023-11-06