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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

PEMIGATINIB

ANDA

Tentative Approval

PEMIGATINIB | A219552 | SANDOZ INC

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDPEMIGATINIB

DMF 388692023

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

Products (2)

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#002 — 4.5MG

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TABLET | TA Date: 2026-06-01 00:00:00

No patent or exclusivity listings for this strength.

#003 — 9MG

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TABLET | TA Date: 2026-06-01 00:00:00