Application 021554
- Type
- NDA
- Sponsor
- BAYER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 212.6MG; EQ 287.5MG BASE | No | No |
| 002 | CIPRO XR | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 425.2MG; EQ 574.9MG BASE | No | No |