Orange Book product
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE 0.75%
Orange Book ANDA 204842 · HIKMA PHARMACEUTICALS · Prescription
Key facts
| Proprietary name | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
|---|---|
| Active ingredients | BUPIVACAINE HYDROCHLORIDE |
| Strength | 0.75% |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA204842 |
| Applicant holder | HIKMA PHARMACEUTICALS |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 11, 2021 |
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.