PRAZIQUANTEL | A208820 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jude Fiorini 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 | Other | 2026-02-11 | Open | Jude Fiorini |
Suitability Petition from Neocubes Pharma, LLC (on behalf of Gelteq ,Ltd.) 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 | Suitability | 2024-09-10 | Granted | Gelteq ,Ltd. |
Suitability Petition from Schafer Veterinary Consultants, LLC on behalf of F... 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 | Suitability | 2019-02-27 | Open | Felix Pharmaceuticals Pvt. Ltd |
Suitability Petition from Schafer Veterinary Consultants, LLC on behalf of F... 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 | Suitability | 2019-02-26 | Granted | Felix Pharmaceuticals Pvt. Ltd |
Suitability Petition from Noble Pharma LLC 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 | Suitability | 2018-06-18 | Granted | Noble Pharma LLC |
Piedmont Animal Health - Citizen Petition 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 | Other | 2012-08-01 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$53.01
per ea
Lowest NADAC/Unit
$53.01
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 49884023183PRAZIQUANTEL 600 MG TABLET | $53.01 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.