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Last Updated: December 12, 2025

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. 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. Seven 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:	0

Medical Subject Heading (MeSH) Categories for 021546

Antimetabolites
Antiviral Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	40MG/ML
Approval Date:	Jul 29, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021546

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	6,524,570*PED	⤷ Get Started Free
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	5,767,097*PED	⤷ Get Started Free
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	6,790,837*PED	⤷ Get Started Free
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	6,472,373*PED	⤷ Get Started Free
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	6,177,074*PED	⤷ Get Started Free
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	6,461,605*PED	⤷ Get Started Free
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	6,172,046*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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