Orange Book product
FLUDROCORTISONE ACETATE 0.1MG
Orange Book ANDA 219251 · ZYDUS LIFESCIENCES GLOBAL FZE · Prescription
Key facts
| Proprietary name | FLUDROCORTISONE ACETATE |
|---|---|
| Active ingredients | FLUDROCORTISONE ACETATE |
| Strength | 0.1MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA219251 |
| Applicant holder | ZYDUS LIFESCIENCES GLOBAL FZE |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 16, 2024 |
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.