FdaApplication
ANDA 078166
Identifiers
- fda_app_no: ANDA078166
Properties
| Property | Value |
|---|---|
| applicant_name | PH HEALTH LTD |
| application_type | ANDA |
| approval_date | 2007-11-27 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG;EQ 574.9MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 212.6MG;EQ 287.5MG BASE | TABLET, EXTENDED RELEASE;ORAL |
2 products