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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.

BALOXAVIR MARBOXIL

ANDA

Tentative Approval

BALOXAVIR MARBOXIL | A217449 | NORWICH

API Supply Chain5 active DMFs

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

CHANGZHOU PHARMACEUTICAL FACTORYBALOXAVIR MARBOXIL

DMF 366572021

MSN LABORATORIES PRIVATE LTDBALOXAVIR MARBOXIL

DMF 367622022

PORTON PHARMA SOLUTIONS LTDBALOXAVIR MARBOXIL

DMF 404552024

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDBALOXAVIR MARBOXIL

DMF 417942025

SUZHOU RYWAY BIOTECH CO LTDBALOXAVIR MARBOXIL

DMF 424272025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 18, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG

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TABLET;ORAL | Approved: 2026-06-17 00:00:00

No patent or exclusivity listings for this strength.

#002 — 80MG

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TABLET;ORAL | Approved: 2026-06-17 00:00:00