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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207366
Company: NAVINTA LLC

Products on ANDA 207366

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIBAVIRIN	RIBAVIRIN	6GM/VIAL	FOR SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207366

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207366Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 207366

RIBAVIRIN

FOR SOLUTION;INHALATION; 6GM/VIAL
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIBAVIRIN	RIBAVIRIN	6GM/VIAL	FOR SOLUTION;INHALATION	Prescription	No	AN	207366	NAVINTA LLC
VIRAZOLE	RIBAVIRIN	6GM/VIAL	FOR SOLUTION;INHALATION	Prescription	Yes	AN	018859	BAUSCH

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