Orange Book product
NAROPIN 1GM/200ML (5MG/ML)
Orange Book NDA 020533 · FRESENIUS KABI USA LLC · Prescription
Key facts
| Proprietary name | NAROPIN |
|---|---|
| Active ingredients | ROPIVACAINE HYDROCHLORIDE |
| Strength | 1GM/200ML (5MG/ML) |
| Dosage form | SOLUTION |
| Route | INJECTION |
| Application | NDA020533 |
| Applicant holder | FRESENIUS KABI USA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jan 4, 2011 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 10–99 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.