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Generated: February 17, 2018

DrugPatentWatch Database Preview

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. Fourteen 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
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 020903
Ingredient-typeNucleoside Analog
Medical Subject Heading (MeSH) Categories for 020903
Suppliers and Packaging for NDA: 020903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REBETOL ribavirin CAPSULE;ORAL 020903 NDA Merck Sharp & Dohme Corp. 0085-1194 N 0085-1194-03
REBETOL ribavirin CAPSULE;ORAL 020903 NDA Merck Sharp & Dohme Corp. 0085-1351 N 0085-1351-05

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:➤ Sign UpPatent Expiration:Mar 21, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent 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:➤ Sign UpPatent 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 020903-001 Jun 3, 1998 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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