Drug application
MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA)
Drugs@FDA BLA 125164 · HOFFMAN-LA ROCHE
Key facts
| Drug name | MIRCERA |
|---|---|
| Active ingredients | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA |
| Application type | BLA |
| Application number | 125164 |
| Company | HOFFMAN-LA ROCHE |
| Dosage forms | SOLUTION, INJECTION |
| Strength | 0.6MG/KG |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Nov 14, 2007 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- None Therapeutic equivalents
- No 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: