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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 207366

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NDA 207366 describes RIBAVIRIN, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Teva, Zydus Pharms Usa, Navinta Llc, Beximco Pharms Usa, Heritage Pharma Avet, and Sandoz, and is included in eleven NDAs. It is available from three suppliers. Additional details are available on the RIBAVIRIN profile page.

The generic ingredient in RIBAVIRIN is ribavirin. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

Summary for 207366

Tradename:	RIBAVIRIN
Applicant:	Navinta Llc
Ingredient:	ribavirin
Patents:	0

Pharmacology for NDA: 207366

Medical Subject Heading (MeSH) Categories for 207366

Antimetabolites
Antiviral Agents

Suppliers and Packaging for NDA: 207366

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIBAVIRIN	ribavirin	FOR SOLUTION;INHALATION	207366	ANDA	Zydus Pharmaceuticals USA Inc.	68382-395	68382-395-04	4 VIAL in 1 CARTON (68382-395-04) / 1 POWDER, FOR SOLUTION in 1 VIAL
RIBAVIRIN	ribavirin	FOR SOLUTION;INHALATION	207366	ANDA	Navinta LLC	68475-003	68475-003-04	4 VIAL in 1 CARTON (68475-003-04) / 1 POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;INHALATION			Strength	6GM/VIAL
Approval Date:	Oct 6, 2016	TE:		RLD:	No

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