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CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

NDA

CEFOTAXIME SODIUM | N050596 | STERIMAX INC

4 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

7 letters from Drugs@FDA

Date	Submission	Document
Mar 24, 2015	SUPPL -42	View Letter (PDF)
Feb 25, 2014	SUPPL -40	View Letter (PDF)
Sep 13, 2011	SUPPL -37	View Letter (PDF)
Jun 2, 2009	SUPPL -36	View Letter (PDF)
Feb 25, 2008	SUPPL -35	View Letter (PDF)
Jun 24, 2004	SUPPL -30	View Letter (PDF)
Jan 18, 2002	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — EQ 20MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 20, 1985

#004 — EQ 40MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 20, 1985

#001 — EQ 20MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 20, 1985

No patent or exclusivity listings for this strength.

#003 — EQ 40MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 20, 1985