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CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

NDA

CEFOTAXIME SODIUM | N050792 | 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 Chain5 active DMFs4 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

ACS DOBFAR SPACEFOTAXIME SODIUM STERILE

DMF 143671999

SANDOZ GMBHCEFOTAXIME SODIUM STERILE

DMF 212022007

NECTAR LIFESCIENCES LTDCEFOTAXIME (NON STERILE DRUG SUBSTANCES INTERMEDIATE)

DMF 243402010

NECTAR LIFESCIENCES LTDCEFOTAXIME SODIUM USP (STERILE) DRUG SUBSTANCE

DMF 247482011

SHANDONG ANHONG PHARMACEUTICAL CO LTDCEFOTAXIME SODIUM

DMF 417322025

WOCKHARDT LTDInactiveCEFOTAXIME SODIUM (STERILE)

DMF 168392003

AUROBINDO PHARMA LTDInactiveCEFOTAXIME SODIUM (STERILE)

DMF 181542005

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFOTAXIME SODIUM STERILE

DMF 248922011

ZHUHAI UNITED LABORATORIES CO LTDInactiveCEFOTAXIME SODIUM USP

DMF 258442012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 11, 2007	SUPPL -2	View Letter (PDF)
Aug 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 2GM BASE

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 29, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 29, 2004