FdaApplication
NDA 021160
Identifiers
- fda_app_no: NDA021160
Properties
| Property | Value |
|---|---|
| applicant_name | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP LLC |
| application_type | NDA |
| approval_date | 2001-04-02 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PHOSLO | CALCIUM ACETATE | 667MG | CAPSULE;ORAL |
| PHOSLO | CALCIUM ACETATE | 333.5MG | CAPSULE;ORAL |
| PHOSLO GELCAPS | CALCIUM ACETATE | 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL |
3 products