FdaApplication
NDA 021507
Identifiers
- fda_app_no: NDA021507
Properties
| Property | Value |
|---|---|
| applicant_name | TAKEDA PHARMACEUTICALS NORTH AMERICA INC |
| application_type | NDA |
| approval_date | 2003-11-14 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PREVACID NAPRAPAC 250 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL |
| PREVACID NAPRAPAC 375 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | 15MG,N/A;N/A,375MG | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL |
| PREVACID NAPRAPAC 500 (COPACKAGED) | LANSOPRAZOLE; NAPROXEN | 15MG,N/A;N/A,500MG | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL |
3 products