Drug application
GYNAZOLE-1 (BUTOCONAZOLE NITRATE)
Drugs@FDA ANDA 200923 · PADAGIS ISRAEL
Key facts
| Drug name | GYNAZOLE-1 |
|---|---|
| Active ingredients | BUTOCONAZOLE NITRATE |
| Application type | ANDA |
| Application number | 200923 |
| Company | PADAGIS ISRAEL |
| Dosage forms | CREAM, VAGINAL |
| Strength | 2% |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Not Applicable |
| Latest submission status date | May 18, 2012 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None 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.