Orange Book product
STALEVO 50 12.5MG;200MG;50MG
Orange Book NDA 021485 · ORION PHARMA · Prescription
Key facts
| Proprietary name | STALEVO 50 |
|---|---|
| Active ingredients | CARBIDOPA, ENTACAPONE, LEVODOPA |
| Strength | 12.5MG;200MG;50MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA021485 |
| Applicant holder | ORION PHARMA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Jun 11, 2003 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.