FdaApplication
NDA 211962
Identifiers
- fda_app_no: NDA211962
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA PHARMS |
| application_type | NDA |
| approval_date | 2019-02-15 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS |
| TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS |
| TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS |
| TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS |
| TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS |
| TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS |
| TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION;INTRAVENOUS |
7 products