Orange Book product
ZOLEDRONIC ACID EQ 5MG BASE/100ML
Orange Book ANDA 205254 · MYLAN LABORATORIES LTD · Prescription
Key facts
| Proprietary name | ZOLEDRONIC ACID |
|---|---|
| Active ingredients | ZOLEDRONIC ACID |
| Strength | EQ 5MG BASE/100ML |
| Dosage form | INJECTABLE |
| Route | INTRAVENOUS |
| Application | ANDA205254 |
| Applicant holder | MYLAN LABORATORIES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 27, 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.