Orange Book product
ZOLEDRONIC ACID EQ 4MG BASE/5ML
Orange Book ANDA 207341 · BPI LABS LLC · Prescription
Key facts
| Proprietary name | ZOLEDRONIC ACID |
|---|---|
| Active ingredients | ZOLEDRONIC ACID |
| Strength | EQ 4MG BASE/5ML |
| Dosage form | INJECTABLE |
| Route | INTRAVENOUS |
| Application | ANDA207341 |
| Applicant holder | BPI LABS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 29, 2017 |
At a glance
- 10–99 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.