CYCLOSPORINE | A065017 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd FDA-2026-P-2004 Felix Pharmaceuticals Pvt. Ltd. filed this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to submit an abbreviated new animal drug application (ANADA) for a generic cyclosporine oral solution for dogs that differs in dosage form from the pioneer pro | Suitability | 2026-02-25 | Open | Felix Pharmaceuticals Pvt. Ltd |
Suitability Petition from Ceva Animal Health, LLC FDA-2017-P-6968 Ceva Animal Health, LLC filed this suitability petition on December 21, 2017 under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA determine an ANADA filing is suitable for a generic cyclosporine oral solution for dogs that differs in dosage form from the refer | Suitability | 2017-12-22 | Open | Ceva Animal Health |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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