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BALOXAVIR MARBOXIL

ANDA

BALOXAVIR MARBOXIL | A217449 | NORWICH PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: XOFLUZA(TE code: AB)

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

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 17, 2026

No patent or exclusivity listings for this strength.

#002 — 80MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 17, 2026