STROMECTOL

FDA-2026-P-3664 · 7 docket documents

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

FDA-2025-P-7371 · 5 docket documents

Argenta filed a suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Animal Drug Application (ANADA) for a generic ivermectin 1.0% oral liquid for horses. The proposed product differs from the reference listed n

FDA-2025-P-1981 · 3 docket documents

Dr. Simone Gold on behalf of America's Frontline Doctors filed this citizen petition under 21 C.F.R. § 10.30 and 21 U.S.C. § 353(b)(3) requesting that the FDA initiate rulemaking to switch ivermectin oral tablets from prescription-only to over-the-counter status for its FDA-approved indications of i

FDA-2025-P-0048 · 10 docket documents

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

FDA-2021-P-0191 · 5 docket documents

Foley & Lardner LLP submitted this petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine that Stromectol (ivermectin) Tablets, 6mg, approved under NDA 050742 by Merck Sharp and Dohme Corp, was not voluntarily withdrawn from sale for safety or e

FDA-1998-P-0118 · 4 docket documents

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

FDA-2016-P-1963 · 3 docket documents

SmartVet Holdings, Inc., through its consultant Schafer Veterinary Consultants, LLC, filed a suitability petition requesting permission to submit an Abbreviated New Animal Drug Application for a different strength formulation of ivermectin pour-on, specifically 15 mg/mL instead of the 5 mg/mL concen

FDA-2013-P-1511 · 3 docket documents

PetaStrip, LLC filed a Suitability Petition under section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application for a soluble film formulation of ivermectin for cats, a different dosage form than the pioneer product Heartguard®

FDA-2013-P-1512 · 3 docket documents

PetaStrip, LLC submitted a suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for a soluble film dosage form of ivermectin for canines, with the same active ingredient amount, dosag

FDA-2012-P-0313 · 3 docket documents

ConVet GmbH & Co. KG submitted a suitability petition under Section 512(n)(3) requesting FDA approval to file an abbreviated new animal drug application (ANADA) for a generic oral ivermectin product for horses in a flavored dissolvable thin film delivery strip form, which differs from the reference