Application 213947
- Type
- ANDA
- Sponsor
- NEXUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | No | No |
| 002 | TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73754 | ORIG | 2023-03-14 |