Application 020586
- Type
- NDA
- Sponsor
- OTSUKA AMERICA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MERETEK UBT KIT (W/ PRANACTIN) | UREA C-13 | FOR SOLUTION;ORAL | 125MG/VIAL | No | No |
| 002 | BREATHTEK UBT FOR H-PYLORI | UREA C-13 | FOR SOLUTION;ORAL | EQ 75MG/POUCH | No | No |