Viewing data from:

BOSUTINIB MONOHYDRATE

ANDA

BOSUTINIB MONOHYDRATE | A209624 | MSN LABORATORIES PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BOSULIF(TE code: AB)

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
Jul 22, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 400MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 12, 2026

No patent or exclusivity listings for this strength.