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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

BOSUTINIB MONOHYDRATE

ANDANot in Orange Book

BOSUTINIB MONOHYDRATE | A209624 | MSN

API Supply Chain6 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDBOSUTINIB [ROUTE CODE BS]

DMF 302182016

ALEMBIC PHARMACEUTICALS LTDBOSUTINIB

DMF 305522016

MSN LABORATORIES PRIVATE LTDBOSUTINIB MONOHYDRATE (FORM-I)

DMF 306832016

ALP PHARM BEIJING CO LTDBOSUTINIB

DMF 312182016

SUN PHARMACEUTICAL INDUSTRIES LTDBOSUTINIB

DMF 361212021

HETERO LABS LTDBOSUTINIB MONOHYDRATE

DMF 393802024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 17, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#002 — EQ 100MG BASE

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TABLET;FILM COATED | Approved: Jun. 12, 2026

#003 — EQ 500MG BASE

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TABLET;FILM COATED | Approved: Jun. 12, 2026

#001 — EQ 400MG BASE

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TABLET;ORAL | Approved: Jun. 12, 2026

No patent or exclusivity listings for this strength.