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Last Updated: November 22, 2024

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 four 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. Eight 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
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:RXDosage:FOR SOLUTION;INHALATIONStrength6GM/VIAL
Approval Date:Oct 6, 2016TE:ANRLD:No

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