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VANTIN

NDA

CEFPODOXIME PROXETIL | N050675 | PFIZER INC

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

6 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2025-P-5433 · 5 docket documents Felix Pharmaceuticals Pvt. Ltd. submitted this Section 512(n)(3) suitability petition requesting permission to file an abbreviated new animal drug application for a generic Cefpodoxime Proxetil powder for oral suspension for dogs, which differs in dosage form from the pioneer product Simplicefo (coa	Suitability	2025-10-16	Denied	Felix Pharmaceuticals Pvt. Ltd.
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2025-P-0983 · 5 docket documents Felix Pharmaceuticals Pvt. Ltd. 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 Cefpodoxime Proxetil powder for oral suspension for dogs, which differ	Suitability	2025-03-28	Denied	Felix Pharmaceuticals Pvt. Ltd.
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2023-P-2728 · 5 docket documents 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 for a generic compressed chewable tablet formulation of Cefpodoxime Proxetil, which differs from the pionee	Suitability	2023-07-03	Granted	Felix Pharmaceuticals Pvt. Ltd.
Suitability Petition from Ray Law Firm, PLLC FDA-2020-P-2234 · 3 docket documents Harry B. Ray of Ray Law Firm, PLLC submitted a citizen petition under section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting approval to file an Abbreviated New Animal Drug Application for Cefpodoxime Proxetil tablets with the addition of a 50mg strength tablet for treating skin inf	Suitability	2020-11-25	Granted	Ray Law Firm, PLLC
Suitability Petition from Douglass Oeller Consulting, Inc (Felix Pharmaceutic... FDA-2016-P-3428 · 6 docket documents Douglass Oeller Consulting, Inc., as US Agent for Felix Pharmaceuticals Pvt. Ltd., filed 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 compressed soft chewable	Suitability	2016-10-20	Open	Douglass Oeller Consulting, Inc (Felix Pharmaceuticals Pvt. Ltd)
Piedmont Animal Health - Citizen Petition FDA-2013-P-0996 · 3 docket documents Piedmont Animal Health filed 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 cefpodoxime proxetil soft chewable tablet for dogs, which differs from the pioneer	Other	2013-09-04	Granted	—

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

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants NCT03491748	Phase 1	Completed	Entasis Therapeutics	99	2018-03-16 → 2019-09-11
Patients Response to Early Switch To Oral:Osteomyelitis Study NCT02099240	Early Phase 1	Terminated	Julio Ramirez	11	2014-03-06 → 2018-11-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain8 active DMFs2 inactive

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

ORCHID PHARMA LTDCEFPODOXIME PROXETIL USP (NON-STERILE BULK)

DMF 185052005

APITORIA PHARMA PRIVATE LTDCEFPODOXIME PROXETIL USP

DMF 189412005

SANDOZ GMBHCEFPODOXIME PROXETIL

DMF 200762006

PURE AND CURE HEALTHCARE PRIVATE LTDCEFPODOXIME PROXETIL

DMF 235722010

NECTAR LIFESCIENCES LTDCEFPODOXIME PROXETIL USP

DMF 270712014

COVALENT LABORATORIES PRIVATE LTDCEFPODOXIME PROXETIL USP

DMF 297912015

QILU ANTIBIOTICS PHARMACEUTICAL CO LTDCEFPODOXIME PROXETIL

DMF 345022020

APITORIA PHARMA PRIVATE LTDCEFPODOXIME PROXETIL USP (PROCESS II)

DMF 395412024

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCEFPODOXIME PROXETIL USP

DMF 151922000

SANDOZ PRIVATE LTDInactiveCEFPODOXIME PROXETIL

DMF 165422003

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2013	SUPPL -18	View Letter (PDF)
Jun 7, 2007	SUPPL -17	View Letter (PDF)
Jun 7, 2004	SUPPL -16	View Letter (PDF)
Nov 20, 1998	SUPPL -15	View Letter (PDF)
Nov 20, 1998	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 50MG 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: Aug 7, 1992

No patent or exclusivity listings for this strength.

#002 — EQ 100MG 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: Aug 7, 1992