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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.

NERATINIB MALEATE

ANDA

Tentative Approval

NERATINIB MALEATE | A216236 | SANDOZ INC

API Supply Chain4 active DMFs

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

MSN LABORATORIES PRIVATE LTDNERATINIB MALEATE (MONOHYDRATE)

DMF 346522020

TAPI NL BVNERATINIB MALEATE MONOHYDRATE

DMF 354572021

TOPHARMAN SHANDONG CO LTDNERATINIB MALEATE

DMF 374072022

SICHUAN KELUN PHARMACEUTICAL CO LTDNERATINIB MALEATE

DMF 432282025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 30, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

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TABLET;ORAL | TA Date: 2022-07-05 00:00:00

No patent or exclusivity listings for this strength.