Orange Book product
FLUOCINOLONE ACETONIDE 0.01%
Orange Book ANDA 207345 · NOVEL LABORATORIES INC · Prescription
Key facts
| Proprietary name | FLUOCINOLONE ACETONIDE |
|---|---|
| Active ingredients | FLUOCINOLONE ACETONIDE |
| Strength | 0.01% |
| Dosage form | OIL |
| Route | TOPICAL |
| Application | ANDA207345 |
| Applicant holder | NOVEL LABORATORIES INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 31, 2023 |
At a glance
- 10–99 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.