FdaApplication
ANDA 216379
Identifiers
- fda_app_no: ANDA216379
Properties
| Property | Value |
|---|---|
| applicant_name | EUGIA PHARMA SPECIALITIES LTD |
| application_type | ANDA |
| approval_date | 2023-05-01 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS |
| TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS |
2 products