Application 217281

Type: ANDA
Sponsor: NOVUGEN

Application Products#

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

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

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	Approval date
A217281-001	LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2024-09-11
A217281-002	LENALIDOMIDE	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2024-09-11
A217281-003	LENALIDOMIDE	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2024-09-11
A217281-004	LENALIDOMIDE	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2024-09-11
A217281-005	LENALIDOMIDE	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2024-09-11
A217281-006	LENALIDOMIDE	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2024-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217281-001	AB
A217281-002	AB
A217281-003	AB
A217281-004	AB
A217281-005	AB
A217281-006	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
2026-08-01 22:54:32	2026-06	A217281-001	LENALIDOMIDE	2.5MG	CAPSULE / ORAL	AB	2024-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-002	LENALIDOMIDE	5MG	CAPSULE / ORAL	AB	2024-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-003	LENALIDOMIDE	10MG	CAPSULE / ORAL	AB	2024-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-004	LENALIDOMIDE	15MG	CAPSULE / ORAL	AB	2024-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-005	LENALIDOMIDE	20MG	CAPSULE / ORAL	AB	2024-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-006	LENALIDOMIDE	25MG	CAPSULE / ORAL	AB	2024-09-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A217281-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217281-006	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Lenalidomide	LENALIDOMIDE	Novugen Pharma (USA) LLC	2166bbdf-eb12-4564-b9e4-b63ca21312bc	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217281 application number: ANDA217281