Application 021554
- Type
- NDA
- Sponsor
- BAYER PHARMS
Application Products#
Product, Drug, Ingredient table| 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 |
Source provenance: Browse the complete Orange Book source catalog.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44480 | ORIG | 2016-02-03 |
| 21732 | ORIG | 2005-12-01 |
| 37214 | ORIG | 2003-09-09 |
| 28105 | ORIG | 2003-09-09 |