Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query
on "020903."
| Active Ingredient: | RIBAVIRIN |
| Dosage Form;Route: | CAPSULE; ORAL |
| Proprietary Name: | REBETOL |
| Applicant: | MERCK SHARP DOHME |
| Strength: | 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** |
| Application Number: | N020903 |
| Product Number: | 001 |
| Approval Date: | Jun 3, 1998 |
| Reference Listed Drug | Yes |
| RX/OTC/DISCN: | RX |
| TE Code: | |
| Patent and Exclusivity Info for this product: | View |
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| Active Ingredient: | RIBAVIRIN |
| Dosage Form;Route: | CAPSULE; ORAL |
| Proprietary Name: | REBETOL |
| Applicant: | MERCK SHARP DOHME |
| Strength: | 200MG |
| Application Number: | N020903 |
| Product Number: | 002 |
| Approval Date: | Jul 25, 2001 |
| Reference Listed Drug | Yes |
| RX/OTC/DISCN: | RX |
| TE Code: | AB |
| Patent and Exclusivity Info for this product: | View |
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| FDA/Center for Drug Evaluation and Research |
| Office of Generic Drugs |
| Division of Labeling and Program Support |
| Update Frequency: |
| Orange Book Data - Monthly |
| Generic Drug Product Information & Patent Information - Daily |
| Orange Book Data Updated Through April, 2013 |
| Patent and Generic Drug Product Data Last Updated: May 24, 2013 |
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