IVERMECTIN | A204154 | EDENBRIDGE PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Argenta FDA-2026-P-6705 Argenta submitted a Suitability Petition pursuant to section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare a generic ivermectin 1.87% oral liquid suitable for submission in an Abbreviated New Animal Drug Application (ANADA) for horses, with the reference liste | Suitability | 2026-06-11 | Open | Argenta |
Withdrawal of Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-3664 Hyman, Phelps & McNamara, P.C. filed a suitability petition on April 2, 2026 requesting permission under 21 C.F.R. § 314.93(b) to submit an Abbreviated New Drug Application for Ivermectin Tablets in 9 mg, 12 mg, and 15 mg strengths, which the firm withdrew on April 27, 2026. | Suitability | 2026-05-04 | Withdrawn | Hyman |
Attachment 1 Heartgard Plus (ivermectin/pyrantel) Chewable Labeling Informati... FDA-1998-P-0118 Phoenix Scientific Inc. filed a petition requesting that the FDA find Heartgard Plus chewable tablets suitable for approval, with the petition addressing labeling information for this combination product containing ivermectin and pyrantel. The submission pertains to regulatory approval pathways for | Suitability | 2017-01-17 | Open | Phoenix Scientific Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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