Details for New Drug Application (NDA): 021511
✉ Email this page to a colleague
NDA 021511 describes COPEGUS, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the COPEGUS profile page.
The generic ingredient in COPEGUS 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.
The generic ingredient in COPEGUS 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.
Medical Subject Heading (MeSH) Categories for 021511
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 3, 2002 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 21, 2005 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
