BILTRICIDE

FDA-2026-P-1583 · 7 docket documents

Jude Fiorini submitted a citizen petition under 21 U.S.C. § 360b requesting that the FDA revoke, suspend, or modify approval and labeling of NexGand COMBO (NADA 141-570), a veterinary fixed-combination animal drug containing esafoxolaner and praziquantel. The petitioner contends that praziquantel do

FDA-2025-P-2524 · 5 docket documents

Novitium Pharma LLC filed this relisting petition under sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. sections 314.122 and 314.161 requesting that the FDA determine whether Biltricide (praziquantel) oral tablet 600 mg, NDA 018714, owned by Bayer Healthcare Phar

FDA-2024-P-4290 · 7 docket documents

Neocubes Pharma LLC, on behalf of Gelteq Ltd, 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 praziquantel oral edible gel for dogs, which differs in do

FDA-2019-P-0941 · 5 docket documents

Schafer Veterinary Consultants, LLC, on behalf of Felix Pharmaceuticals Pvt. Ltd., filed a suitability petition requesting permission to submit an abbreviated new animal drug application (ANADA) for a generic chewable tablet formulation of Praziquantel and Pyrantel Pamoate that differs from the pion

FDA-2019-P-0916 · 5 docket documents

Schafer Veterinary Consultants, LLC, on behalf of Felix Pharmaceuticals Pvt. Ltd., submitted a 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 generic praziquantel compressed chewable

FDA-2018-P-2344 · 6 docket documents

Noble Pharma, 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 generic soft chewable scored tablet formulation of praziquantel for dogs, which differs in dos

FDA-2012-P-0794 · 3 docket documents

Piedmont Animal Health submitted this 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 generic combination of praziquantel, pyrantel pamoate, and febantel in a soft chewable