Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020903

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REBETOL (RIBAVIRIN)
200MG
Marketing Status: Prescription
Active Ingredient: RIBAVIRIN
Proprietary Name: REBETOL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020903
Product Number: 002
Approval Date: Jul 25, 2001
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
REBETOL (RIBAVIRIN)
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

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