All regulations
Nonrulemaking
FDA
FDA-2026-P-2004
Requests that the FDA grant permission to file an application for an abbreviated new animal drug application for a generic Oral solution for cyclosporine that differs from the pioneer product, Atopica (cyclosporine capsules), sponsored by Elanco US Inc. under NADA 141-218.
Documents
6
Comments
0
Description
CLOSED
Key Dates
Comment Period OpensFeb 25, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CVM
Suitability Petition
Felix Pharmaceuticals Pvt Ltd
grant permission to file an application for an
abbreviated new animal drug application
for a generic Oral solution
for cyclosporine that differs from the
pioneer product Atopica cyclosporine capsules
Data from Regulations.gov