Orange Book product
VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL
Orange Book ANDA 065397 · MYLAN LABORATORIES LTD · Prescription
Key facts
| Proprietary name | VANCOMYCIN HYDROCHLORIDE |
|---|---|
| Active ingredients | VANCOMYCIN HYDROCHLORIDE |
| Strength | EQ 500MG BASE/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA065397 |
| Applicant holder | MYLAN LABORATORIES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 30, 2008 |
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.