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CEFOTAXIME

ANDA

CEFOTAXIME SODIUM | A064201 | FRESENIUS KABI USA LLC

2 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 24, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 10GM BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 24, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 20GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 24, 2000