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Last Updated: November 21, 2024

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. 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. Eight 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:	0

Medical Subject Heading (MeSH) Categories for 020903

Antimetabolites
Antiviral Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy
Approval Date:	Jun 3, 1998	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 25, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 020903

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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