Orange Book product
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200MG/100ML (2MG/ML)
Orange Book ANDA 078698 · HIKMA FARMACEUTICA (PORTUGAL) SA · Prescription
Key facts
| Proprietary name | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | FLUCONAZOLE |
| Strength | 200MG/100ML (2MG/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA078698 |
| Applicant holder | HIKMA FARMACEUTICA (PORTUGAL) SA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 30, 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.