Skip to contentApplication 215875
- Type
- NDA
- Sponsor
- PH HEALTH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADRENALIN | EPINEPHRINE | SOLUTION;INTRAVENOUS | 2MG/250ML (8MCG/ML) | Yes | Yes |
| 002 | ADRENALIN | EPINEPHRINE | SOLUTION;INTRAVENOUS | 4MG/250ML (16MCG/ML) | Yes | Yes |
| 003 | ADRENALIN | EPINEPHRINE | SOLUTION;INTRAVENOUS | 5MG/250ML (20MCG/ML) | Yes | Yes |
| 004 | ADRENALIN | EPINEPHRINE | SOLUTION;INTRAVENOUS | 8MG/250ML (32MCG/ML) | Yes | Yes |
| 005 | ADRENALIN | EPINEPHRINE | SOLUTION;INTRAVENOUS | 10MG/250ML (40MCG/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77042 | ORIG | 2023-12-19 |
| 75918 | SUPPL | 2023-10-24 |
| 74051 | ORIG | 2023-04-24 |
| 74040 | ORIG | 2023-04-24 |