Orange Book product
HALOBETASOL PROPIONATE 0.05%
Orange Book ANDA 078162 · COSETTE PHARMACEUTICALS NC LABORATORIES LLC · Prescription
Key facts
| Proprietary name | HALOBETASOL PROPIONATE |
|---|---|
| Active ingredients | HALOBETASOL PROPIONATE |
| Strength | 0.05% |
| Dosage form | CREAM |
| Route | TOPICAL |
| Application | ANDA078162 |
| Applicant holder | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Apr 24, 2007 |
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.