Drug application
REBETOL (RIBAVIRIN)
Drugs@FDA NDA 020903 · MERCK SHARP DOHME
Key facts
| Drug name | REBETOL |
|---|---|
| Active ingredients | RIBAVIRIN |
| Application type | NDA |
| Application number | 020903 |
| Company | MERCK SHARP DOHME |
| Dosage forms | CAPSULE, ORAL |
| Strength | 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Jun 3, 1998 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: