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IVERMECTIN

ANDA

IVERMECTIN | A210225 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: SOOLANTRA(TE code: AB)

Citizen Petitions

2 petitions (1 open) from Regulations.gov

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	Suitability	2026-05-04	Withdrawn	Hyman

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

HOVIONE PHARMASCIENCE LTDIVERMECTIN USP

DMF 213952008

ZHEJIANG HISUN PHARMACEUTICAL CO LTDIVERMECTIN USP

DMF 216242008

INDUSTRIALE CHIMICA SRLIVERMECTIN PH. FUR.

DMF 364942021

HEBEI MEIHE PHARMACEUTICAL CO LTDIVERMECTIN

DMF 385532023

SHANGHAI TONGREN PHARMACEUTICAL CO LTDInactiveIVERMECTIN

DMF 130371998

DELTA TECH LTDInactiveIVERMECTIN

DMF 176732004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Apr 13, 2020

No patent or exclusivity listings for this strength.