Orange Book product
VIVACAINE 0.5%;0.0091MG/ML
Orange Book ANDA 077250 · SEPTODONT INC · Prescription
Key facts
| Proprietary name | VIVACAINE |
|---|---|
| Active ingredients | BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE |
| Strength | 0.5%;0.0091MG/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA077250 |
| Applicant holder | SEPTODONT INC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Sep 27, 2006 |
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.