Application 212609

Type: ANDA
Sponsor: CIPLA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	CAPSULE;ORAL	EQ 100MG BASE	No	No
002	NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212609-001	NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2026-04-02
A212609-002	NINTEDANIB ESYLATE	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB		2026-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212609-001	AB
A212609-002	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	A212609-001	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2026-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212609-002	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2026-04-02	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212609-001	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2026-04-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212609-002	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2026-04-02	`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	A212609-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212609-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212609-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212609-002	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nintedanib Capsules, 100 mg and 150 mg	NINTEDANIB	EXELAN PHARMACEUTICALS INC.	60d8104e-cb6c-4f4f-8159-95ed57346ffa	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212609 application number: ANDA212609
Nintedanib	NINTEDANIB	Cipla USA Inc.	4d017c42-a823-452d-bc6f-0491dd9823e3	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212609 application number: ANDA212609