FdaApplication
NDA 209481
Identifiers
- fda_app_no: NDA209481
Properties
| Property | Value |
|---|---|
| applicant_name | MYLAN LABORATORIES LTD |
| application_type | NDA |
| approval_date | 2018-07-10 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER;INTRAVENOUS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.75GM BASE/VIAL | POWDER;INTRAVENOUS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/VIAL | POWDER;INTRAVENOUS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER;INTRAVENOUS |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/VIAL | POWDER;INTRAVENOUS |
6 products