Drug application
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Drugs@FDA NDA 209481 · MYLAN LABS LTD
Key facts
| Drug name | VANCOMYCIN HYDROCHLORIDE |
|---|---|
| Active ingredients | VANCOMYCIN HYDROCHLORIDE |
| Application type | NDA |
| Application number | 209481 |
| Company | MYLAN LABS LTD |
| Dosage forms | POWDER, INTRAVENOUS |
| Strength | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Jul 10, 2018 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: