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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-3367
Requests that the FDA make a determination from the Food and Drug Administration (FDA) that we may submit an Abbreviated New Animal Drug Application for a generic Pergolide Tablets, USP product in two strengths: 0.5 mg and 1 mg pergolide per tablet.
Documents
5
Comments
0
Key Dates
Comment Period OpensMar 30, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Keywords
CVM
Suitability Petition
Cronus Pharma Specialities India Pvt Ltd
make a determination that we may submit an
Abbreviated New Animal Drug Application
for a generic Pergolide Tablets
USP product in two strengths
0 5 mg and 1 mg pergolide per tablet
Data from Regulations.gov