Application 213165

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	20MG	No	No
005	LENALIDOMIDE	LENALIDOMIDE	CAPSULE;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213165-001	LENALIDOMIDE	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2026-02-02
A213165-002	LENALIDOMIDE	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2026-02-02
A213165-003	LENALIDOMIDE	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2026-02-02
A213165-004	LENALIDOMIDE	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2026-02-02
A213165-005	LENALIDOMIDE	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2026-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213165-001	AB
A213165-002	AB
A213165-003	AB
A213165-004	AB
A213165-005	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213165-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2026-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2026-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2026-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-004	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2026-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-005	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2026-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213165-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2026-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2026-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2026-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-004	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2026-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-005	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2026-02-02	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-001	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2026-02-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-002	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2026-02-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-003	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2026-02-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-004	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2026-02-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-005	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2026-02-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213165-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213165-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213165-005	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213165-005	AB	1	`a50c72e98297…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lenalidomide	LENALIDOMIDE	Teva Pharmaceuticals, Inc.	1b2716cf-24b4-4157-a218-58ede63917bd	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
LENALIDOMIDE	LENALIDOMIDE	Amneal Pharmaceuticals NY LLC	da7b5dda-79ed-4c4a-88aa-52394fdc7c54	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LENALIDOMIDE generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Accord Healthcare Inc.	9c414531-a3bf-455a-aca7-9e716f42099a	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Devatis Inc.	9959cd7e-12b6-4b59-8205-d5f6e7e7d09b	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Novugen Pharma (USA) LLC	2166bbdf-eb12-4564-b9e4-b63ca21312bc	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
LENALIDOMIDE	LENALIDOMIDE	Alvogen, Inc.	adee5af1-c9ab-c0c7-e400-dea7d2a0d4be	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LENALIDOMIDE generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Apotex Corp.	9943e098-20b0-dbb3-af12-7816eedd3f70	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
LENALIDOMIDE	LENALIDOMIDE	Padagis US LLC	dffe719b-4f61-47e2-b71c-673322d487f5	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LENALIDOMIDE generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	BIOCON PHARMA INC.,	ed7a3099-ce31-4865-b212-358d9ff6261b	2025-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
lenalidomide	LENALIDOMIDE	Cipla USA Inc.	ba2a07fd-ca60-40bc-b79b-9caf81900fa3	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lenalidomide generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Sun Pharmaceutical Industries, Inc.	84d9dec7-9250-4dbd-9a0d-23e75f111892	2024-12-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
LENALIDOMIDE	LENALIDOMIDE	Zydus Lifesciences Limited	fd23328f-b019-4c14-80d9-4ebd997f26b2	2024-11-30		Name fallback brand name: LENALIDOMIDE generic name: LENALIDOMIDE
LENALIDOMIDE	LENALIDOMIDE	Camber Pharmaceuticals, Inc.	f27092f3-3977-4f4a-b214-45309e136e46	2024-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LENALIDOMIDE generic name: LENALIDOMIDE
lenalidomide	LENALIDOMIDE	EXELAN PHARMACEUTICALS INC.	682e8a86-9f49-45db-a2ea-403ee1dc62d2	2024-06-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: lenalidomide generic name: LENALIDOMIDE
LENALIDOMIDE	LENALIDOMIDE	EXELAN PHARMACEUTICALS INC.	85f5db5d-8f76-46f6-b975-6acda8c4b2c8	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: LENALIDOMIDE generic name: LENALIDOMIDE
LENALIDOMIDE	LENALIDOMIDE	Zydus Pharmaceuticals USA Inc.	c98fb504-76d0-4c25-9c0b-412885828a7a	2024-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LENALIDOMIDE generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Mylan Pharmaceuticals Inc.	76f6c1e7-985b-43d9-892c-849df50ae80e	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Aurobindo Pharma Limited	51bfdd53-8fd9-4f86-bebe-75de29e6379d	2023-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
Lenalidomide	LENALIDOMIDE	Dr. Reddy's Laboratories Inc.	ca8cc2cc-c856-e676-4f60-1e46d7b53d73	2023-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lenalidomide generic name: LENALIDOMIDE
Revlimid	LENALIDOMIDE	Celgene Corporation	5fa97bf5-28a2-48f1-8955-f56012d296be	2023-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LENALIDOMIDE