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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

BALOXAVIR MARBOXIL

ANDANot in Orange Book

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: Jun. 17, 2026

No patent or exclusivity listings for this strength.

#002 — 80MG

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TABLET;ORAL | Approved: Jun. 17, 2026