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CEFUROXIME SODIUM

ANDA

CEFUROXIME SODIUM | A064192 | TEVA PHARMACEUTICALS USA

2 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs9 inactive

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

ACS DOBFAR SPACEFUROXIME SODIUM (STERILE BULK)

DMF 132051998

FARMABIOS SPACEFUROXIME SODIUM STERILE USP

DMF 187222005

GLAXOSMITHKLINE LLCCEFUROXIME SODIUM

DMF 244112011

NECTAR LIFESCIENCES LTDCEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE

DMF 246272011

STERILE INDIA PVT LTDCEFUROXIME SODIUM USP (STERILE)

DMF 299832016

ELI LILLY AND COInactiveCEFUROXIME SODIUM

DMF 136751998

FARMABIOS SRLInactiveCEFUROXIME SODIUM STERILE

DMF 141371999

FRESENIUS KABI ANTI INFECTIVES SRLInactiveCEFUROXIME SODIUM STERILE

DMF 155502001

FARMABIOS SPAInactiveCEFUROXIME SODIUM (INTERMEDIATE)

DMF 163252002

WOCKHARDT LTDInactiveCEFUROXIME SODIUM (STERILE)

DMF 166492003

AUROBINDO PHARMA LTDInactiveCEFUROXIME SODIUM

DMF 185302005

AUROBINDO PHARMA LTDInactiveCEFUROXIME SODIUM (STERILE) USP

DMF 188852005

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveCEFUROXIME SODIUM (STERILE)

DMF 203312007

ZHUHAI UNITED LABORATORIES CO LTDInactiveCEFUROXIME SODIUM USP

DMF 261142012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 13, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 1.5GM BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Apr 16, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 750MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Apr 16, 1998