Application 009319
- Type
- NDA
- Sponsor
- FOREST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 006 | AMBENYL | BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE | SYRUP;ORAL | 12.5MG/5ML;10MG/5ML | No | No |
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 006 | AMBENYL | BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE | SYRUP;ORAL | 12.5MG/5ML;10MG/5ML | No | No |