Application 006146
- Type
- NDA
- Sponsor
- MCNEIL CONS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
| 002 | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |