Drug application
CIPROFLOXACIN EXTENDED RELEASE (CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE)
Drugs@FDA ANDA 078166 · PH HEALTH
Key facts
| Drug name | CIPROFLOXACIN EXTENDED RELEASE |
|---|---|
| Active ingredients | CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 078166 |
| Company | PH HEALTH |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | 425.2MG;EQ 574.9MG BASE |
| Marketing status | Discontinued |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Nov 27, 2007 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.