Application 019099
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/100ML | Yes | Yes |
| 002 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% | DOPAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 80MG/100ML | Yes | Yes |
| 003 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER | DOPAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 160MG/100ML | Yes | Yes |
| 004 | DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% | DOPAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 320MG/100ML | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 1227 | SUPPL | 2005-01-11 |