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Last Updated: January 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207366

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NDA 207366 describes RIBAVIRIN, which is a drug marketed by Aurobindo Pharma, Casi Pharms Inc, Teva, Zydus Pharms Usa, Navinta Llc, Beximco Pharms Usa, Heritage Pharma, Kadmon Pharms Llc, 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. Seven suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 207366
Applicant:Navinta Llc
Formulation / Manufacturing:see details
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

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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