Application 017941
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | SUDAFED 12 HOUR | PSEUDOEPHEDRINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |