FdaApplication
NDA 050757
Identifiers
- fda_app_no: NDA050757
Properties
| Property | Value |
|---|---|
| applicant_name | TAKEDA PHARMACEUTICALS USA INC |
| application_type | NDA |
| approval_date | 1997-12-02 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PREVPAC (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL |
1 product