FdaApplication
NDA 021636
Identifiers
- fda_app_no: NDA021636
Properties
| Property | Value |
|---|---|
| applicant_name | SALIX PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2004-06-15 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
| ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
2 products