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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. Twelve 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

Tradename:
REBETOL
Applicant:
Schering
Ingredient:
ribavirin
Patents:6
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

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
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

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering
REBETOL
ribavirin
SOLUTION;ORAL021546-001Jul 29, 20035,767,097*PED► subscribe
Schering
REBETOL
ribavirin
SOLUTION;ORAL021546-001Jul 29, 20036,063,772*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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