Orange Book product
FLUDROCORTISONE ACETATE 0.1MG
Orange Book ANDA 220308 · HIBROW HEALTHCARE PRIVATE LTD · Prescription
Key facts
| Proprietary name | FLUDROCORTISONE ACETATE |
|---|---|
| Active ingredients | FLUDROCORTISONE ACETATE |
| Strength | 0.1MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA220308 |
| Applicant holder | HIBROW HEALTHCARE PRIVATE LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 10, 2026 |
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.