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CEDAX

NDA

CEFTIBUTEN DIHYDRATE | N050686 | BURKE THERAPEUTICS LLC

2 strengths0 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 Orchid Healthcare (A Division of Orchid Pharma Ltd.) FDA-2016-P-3560 Orchid Healthcare, a division of Orchid Pharma Ltd., filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine the discontinued formulation of Pernix Therapeutics LLC's Cedax (ceftibuten for oral suspension) 90 mg base/5 mL and	505(q)	2016-10-27	Withdrawn	Orchid Healthcare (A Division of Orchid Pharma Ltd.)

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ACS DOBFAR SPACEFTIBUTEN DIHYDRATE

DMF 423462025

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Dec 20, 1995

No patent or exclusivity listings for this strength.

#002 — EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Dec 20, 1995