Application 209624

Type: ANDA
Sponsor: MSN LABORATORIES PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BOSUTINIB	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	400MG	No	No
002	BOSUTINIB	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	EQ 100MG BASE	No	No
003	BOSUTINIB	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	EQ 500MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209624-001	BOSUTINIB MONOHYDRATE	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET / ORAL	AB		2026-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209624-001	AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A209624-001	PC	2026-11-23

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
2026-09-14 22:38:34	2026-08	A209624-001	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET / ORAL	AB	2026-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209624-001	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET / ORAL	AB	2026-06-12	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209624-001	BOSUTINIB MONOHYDRATE	EQ 400MG BASE	TABLET / ORAL	AB	2026-06-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209624-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209624-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209624-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	A209624-001	PC	2026-11-23	`84e616aacf4f…`

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
Bosutinib	BOSUTINIB	Dr. Reddy's Laboratories Inc.	cb7a8d1d-07c0-462d-960f-214d44705e76	2026-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209624 application number: ANDA209624

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62174	ORIG	2020-03-17