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BANAN

NDA

CEFPODOXIME PROXETIL | N050688 | 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

No FDA citizen petitions matched from Regulations.gov

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

7 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2000	SUPPL -10	View Letter (PDF)
Feb 10, 2000	SUPPL -12	View Letter (PDF)
Feb 10, 2000	SUPPL -13	View Letter (PDF)
Feb 10, 2000	SUPPL -6	View Letter (PDF)
Feb 10, 2000	SUPPL -8	View Letter (PDF)
Feb 10, 2000	SUPPL -9	View Letter (PDF)
Feb 10, 2000	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG BASE/5ML

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Aug 7, 1992

No patent or exclusivity listings for this strength.

#002 — EQ 50MG BASE/5ML

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Aug 7, 1992