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Last Updated: June 13, 2021

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Details for New Drug Application (NDA): 020903


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NDA 020903 describes REBETOL, which is a drug marketed by Merck Sharp Dohme and Schering and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the REBETOL profile page.

The generic ingredient in REBETOL is ribavirin. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 020903
Tradename:REBETOL
Applicant:Merck Sharp Dohme
Ingredient:ribavirin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020903
Paragraph IV (Patent) Challenges for 020903
Tradename Dosage Ingredient NDA Submissiondate
REBETOL CAPSULE;ORAL ribavirin 020903

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
Approval Date:Jun 3, 1998TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 25, 2001TE:ABRLD:Yes

Expired US Patents for NDA 020903

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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Moodys
Merck
Express Scripts
Baxter

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