Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217449
Company: NORWICH

Products on ANDA 217449

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BALOXAVIR MARBOXIL	BALOXAVIR MARBOXIL	40MG	TABLET;ORAL	Prescription	AB	No	No
BALOXAVIR MARBOXIL	BALOXAVIR MARBOXIL	80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2023	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217449Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217449

BALOXAVIR MARBOXIL

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALOXAVIR MARBOXIL	BALOXAVIR MARBOXIL	40MG	TABLET;ORAL	Prescription	No	AB	217449	NORWICH
XOFLUZA	BALOXAVIR MARBOXIL	40MG	TABLET;ORAL	Prescription	Yes	AB	210854	GENENTECH INC

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALOXAVIR MARBOXIL	BALOXAVIR MARBOXIL	80MG	TABLET;ORAL	Prescription	No	AB	217449	NORWICH
XOFLUZA	BALOXAVIR MARBOXIL	80MG	TABLET;ORAL	Prescription	Yes	AB	210854	GENENTECH INC