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CEFOXITIN IN PLASTIC CONTAINER

ANDA

CEFOXITIN SODIUM | A200938 | SAMSON MEDICAL TECHNOLOGIES LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Samson Medical Technologies, LLC - Citizen Petition FDA-2010-P-0125 · 5 docket documents Samson Medical Technologies, LLC filed this citizen petition pursuant to 21 CFR 314.161 requesting that the FDA determine that Mefoxin (Cefoxitin for Injection, USP) under NDA 50-517 was not discontinued due to safety or efficacy issues, to enable the company to proceed with ANDA 200938 for a 100-gr	505(q)	2010-03-09	Withdrawn	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Nov 20, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 100GM BASE

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Nov 16, 2015

No patent or exclusivity listings for this strength.