FdaApplication
NDA 020586
Identifiers
- fda_app_no: NDA020586
Properties
| Property | Value |
|---|---|
| applicant_name | OTSUKA AMERICA PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1996-09-17 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BREATHTEK UBT FOR H-PYLORI | UREA C-13 | EQ 75MG/POUCH | FOR SOLUTION;ORAL |
| MERETEK UBT KIT (W/ PRANACTIN) | UREA C-13 | 125MG/VIAL | FOR SOLUTION;ORAL |
2 products