Product Details for NDA 020903
REBETOL (RIBAVIRIN)
200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
Marketing Status: Discontinued
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
Marketing Status: Discontinued
Active Ingredient: RIBAVIRIN
Proprietary Name: REBETOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020903
Product Number: 001
Approval Date: Jun 3, 1998
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
REBETOL (RIBAVIRIN)
Proprietary Name: REBETOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020903
Product Number: 001
Approval Date: Jun 3, 1998
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: RIBAVIRIN
Proprietary Name: REBETOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020903
Product Number: 002
Approval Date: Jul 25, 2001
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: REBETOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020903
Product Number: 002
Approval Date: Jul 25, 2001
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status: Discontinued
Patent and Exclusivity Information