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CEFTRIAXONE

ANDA

CEFTRIAXONE SODIUM | A065262 | TEVA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs12 inactive

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

SANDOZ GMBHCEFTRIAXONE SODIUM (STERILE)

DMF 164672003

ORCHID PHARMA LTDCEFTRIAXONE SODIUM

DMF 172572004

ACS DOBFAR SPACEFTRIAXONE SODIUM NON STERILE USP

DMF 175412004

FRESENIUS KABI IPSUM SRLCEFTRIAXONE SODIUM STERILE

DMF 196272006

NECTAR LIFESCIENCES LTDCEFTRIAXONE SODIUM (NON-STERILE) DRUG SUBSTANCE

DMF 241342010

NECTAR LIFESCIENCES LTDCEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE

DMF 243542010

NECTAR LIFESCIENCES LTDCEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE (PROCESS-II)

DMF 255612012

STERILE INDIA PVT LTDCEFTRIAXONE SODIUM USP (STERILE)

DMF 299822016

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDCEFTRIAXONE SODIUM (NON-STERILE BULK) USP

DMF 335012019

ROCHE PHARMACEUTICALS DIV HOFFMANN LAROCHE INCInactiveCEFTRIAXONE SODIUM

DMF 136561998

LUPIN LTDInactiveCEFTRIAXONE SODIUM USP (STERILE )

DMF 159312002

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveCEFTRIAXONE SODIUM

DMF 177142004

AUROBINDO PHARMA LTDInactiveCEFTRIAXONE SODIUM

DMF 178242004

AUROBINDO PHARMA LTDInactiveCEFTRIAXONE SODIUM (STERILE)

DMF 179112004

ANTIBIOTICOS DO BRASIL LTDAInactiveCEFTRIAXONE SODIUM USP (STERILE BULK)

DMF 193372006

KYONGBO PHARMACEUTICAL CO LTDInactiveCEFTRIAXONE SODIUM STERILE

DMF 200772006

ACS DOBFAR SPAInactiveCEFTRIAXONE SODIUM USP STERILE 100 GRAMS

DMF 206362007

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFTRIAXONE SODIUM (NON-STERILE)

DMF 241602010

SANDOZ INDUSTRIAL PRODUCTS GMBHInactiveCEFTRIAXONE SODIUM STERILE

DMF 244122010

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFTRIAXONE SODIUM STERILE

DMF 253812011

ZHUHAI UNITED LABORATORIES CO LTDInactiveCEFTRIAXONE SODIUM USP

DMF 259462012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 1GM BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Jun 29, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 2GM BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Jun 29, 2006