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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

5 petitions (5 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - SIMPLICEF- cefpodoxime proxetil tablet RE Suitability Petition... FDA-2023-P-2728 Felix Pharmaceuticals Pvt. Ltd. filed a citizen petition requesting FDA suitability determination for SIMPLICEF, a cefpodoxime proxetil tablet formulation. The petition seeks regulatory eligibility to pursue abbreviated new drug application (ANDA) pathways for this antibiotic product.	Suitability	2023-07-03	Open	Felix Pharmaceuticals Pvt. Ltd.
Attachment 2 - Cefpodoxime Proxetil Chewable Tablets RE Suitability Petition ... FDA-2023-P-2728 Felix Pharmaceuticals Pvt. Ltd. filed a citizen petition regarding cefpodoxime proxetil chewable tablets, requesting a determination of suitability for approval under the abbreviated new drug application pathway.	Suitability	2023-07-03	Open	Felix Pharmaceuticals Pvt. Ltd.
Amendment to Suitability Petition from Douglass Oeller Consulting, Inc. (Feli... FDA-2016-P-3428 Douglass Oeller Consulting, Inc. as US Agent for Felix Pharmaceuticals Pvt. Ltd. submitted an amendment to suitability petition FDA-2016-P-3428 under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act to correct a typographical error in the NADA number for the reference listed new animal d	Suitability	2016-11-29	Open	Douglass Oeller Consulting
Suitability Petition from Douglass Oeller Consulting, Inc (Felix Pharmaceutic... FDA-2016-P-3428 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
Attachment 1 Simplicef re Suitability Petition from Douglass Oeller Consultin... FDA-2016-P-3428 Douglass Oeller Consulting, Inc., on behalf of Felix Pharmaceuticals Pvt. Ltd., filed a petition regarding Simplicef requesting that the FDA determine the suitability of the product for approval or continued marketing. The petition seeks FDA guidance on the regulatory pathway and manufacturing or fo	Suitability	2016-10-20	Open	Douglass Oeller Consulting

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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