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BANAN

NDA

CEFPODOXIME PROXETIL | N050687 | SANKYO USA CORP

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

3 petitions (2 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.
Citizen Petition from Association of Independent Banana Producers of Guatemala FDA-2019-P-1781 The Association of Independent Banana Producers of Guatemala filed this citizen petition requesting modifications to 21 CFR § 112.44(a)(2) and exclusion of 21 CFR § 112.43(b) under the Food Safety Modernization Act's Subpart E, arguing that surface water treatment requirements are untenable for bana	Other	2019-04-16	Withdrawn	Association of Independent Banana Producers of Guatemala

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

7 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2000	SUPPL -4	View Letter (PDF)
Feb 10, 2000	SUPPL -7	View Letter (PDF)
Feb 10, 2000	SUPPL -9	View Letter (PDF)
Feb 10, 2000	SUPPL -10	View Letter (PDF)
Feb 10, 2000	SUPPL -12	View Letter (PDF)
Feb 10, 2000	SUPPL -8	View Letter (PDF)
Feb 10, 2000	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 7, 1992

No patent or exclusivity listings for this strength.

#002 — EQ 200MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 7, 1992