Orange Book product
GYNAZOLE-1 2%
Orange Book ANDA 200923 · PADAGIS ISRAEL PHARMACEUTICALS LTD · Prescription
Key facts
| Proprietary name | GYNAZOLE-1 |
|---|---|
| Active ingredients | BUTOCONAZOLE NITRATE |
| Strength | 2% |
| Dosage form | CREAM |
| Route | VAGINAL |
| Application | ANDA200923 |
| Applicant holder | PADAGIS ISRAEL PHARMACEUTICALS LTD |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | May 18, 2012 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.