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Generated: April 20, 2019

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Details for New Drug Application (NDA): 021546

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NDA 021546 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. Thirteen suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 021546
Tradename:REBETOL
Applicant:Schering
Ingredient:ribavirin
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021546
Medical Subject Heading (MeSH) Categories for 021546
Suppliers and Packaging for NDA: 021546
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REBETOL ribavirin SOLUTION;ORAL 021546 NDA Merck Sharp & Dohme Corp. 0085-1318 0085-1318-01 1 BOTTLE in 1 CARTON (0085-1318-01) > 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength40MG/ML
Approval Date:Jul 29, 2003TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 5, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021546

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 ➤ Sign Up ➤ Sign Up
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 ➤ Sign Up ➤ Sign Up
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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