FdaApplication
NDA 021473
Identifiers
- fda_app_no: NDA021473
Properties
| Property | Value |
|---|---|
| applicant_name | BAYER HEALTHCARE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2002-12-13 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
2 products