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BOSUTINIB MONOHYDRATE

ANDA

BOSUTINIB MONOHYDRATE | A209543 | ALEMBIC PHARMACEUTICALS LTD

2 strengths0 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.

Products (2)

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#001 — EQ 100MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 23, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 23, 2025