Application 217338
- Type
- NDA
- Sponsor
- RB HLTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM | TABLET, EXTENDED RELEASE;ORAL | 30MG;600MG;110MG | Yes | Yes |