Orange Book product
ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML)
Orange Book ANDA 206166 · INFORLIFE SA · Prescription
Key facts
| Proprietary name | ROPIVACAINE HYDROCHLORIDE |
|---|---|
| Active ingredients | ROPIVACAINE HYDROCHLORIDE |
| Strength | 400MG/200ML (2MG/ML) |
| Dosage form | SOLUTION |
| Route | INJECTION |
| Application | ANDA206166 |
| Applicant holder | INFORLIFE SA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 11, 2018 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No 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.