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CORTISPORIN

NDA

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | N050479 | MONARCH PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley & Lardner LLP FDA-2018-P-3883 · 4 docket documents Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Cortisporin Otic Solution (Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, NDA #050479), a reference listed drug, was d	505(q)	2018-10-12	Granted	Foley & Lardner LLP

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 12, 2025	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.