IVERMECTIN | N050742 | MERCK SHARP AND DOHME CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-3664 The law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Ivermectin Tablets in 9 mg, 12 mg, and 15 mg strengths suitable for submissi | Suitability | 2026-04-03 | Withdrawn | Hyman |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-0048 Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Ivermectin Tablets at 9 mg and 12 mg strengths, which would provide convenient higher-dose al | Suitability | 2025-01-07 | Open | Senores Pharmaceuticals |
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.
No patent or exclusivity listings for this strength.