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Generated: March 26, 2019

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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 are three patents 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. Thirteen 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:2
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 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
Patent:➤ Try a Free TrialPatent Expiration:Mar 21, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 21, 2018Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 25, 2001TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 21, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020903

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
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Farmers Insurance
Mallinckrodt
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Baxter

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