Viewing data from:

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER

NDA

CEFOXITIN SODIUM | N065214 | B BRAUN MEDICAL 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs4 inactive

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

ACS DOBFAR SPACEFOXITIN SODIUM (STERILE BULK)

DMF 129761998

ORCHID PHARMA LTDCEFOXITIN SODIUM USP (STERILE)

DMF 181492005

ANTIBIOTICOS DO BRASIL LTDAInactiveCEFOXITIN SODIUM STERILE BULK

DMF 197892006

ACS DOBFAR SPAInactiveCEFOXITIN SODIUM USP STERILE 100 GRAMS

DMF 206352007

FRESENIUS KABI ANTI INFECTIVES SRLInactiveCEFOXITIN SODIUM (STERILE) DRUG SUBSTANCE

DMF 206982007

AUROBINDO PHARMA LTDInactiveCEFOXITIN SODIUM USP (STERILE BULK)

DMF 213292008

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 30, 2019	SUPPL -16	View Letter (PDF)
Jun 6, 2013	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1GM BASE/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 10, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 2GM BASE/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 10, 2006