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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 are six 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. There is one tentative approval for this compound. Additional details are available on the ribavirin profile page.

Summary for NDA: 021546

Therapeutic Class:Antivirals

Pharmacology for NDA: 021546

Ingredient-typeNucleoside Analog

Suppliers and Packaging for NDA: 021546

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength40MG/ML
Approval Date:Jul 29, 2003TE:RLD:Yes
Patent:6,172,046*PEDPatent Expiration:Mar 21, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,177,074*PEDPatent Expiration:May 1, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,461,605*PEDPatent Expiration:May 1, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021546

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
SOLUTION;ORAL021546-001Jul 29, 20035,767,097*PED► subscribe
SOLUTION;ORAL021546-001Jul 29, 20036,063,772*PED► subscribe
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