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CEFUROXIME AXETIL

ANDA

CEFUROXIME AXETIL | A065043 | RANBAXY LABORATORIES LTD

3 strengths0 unique patents0 unique exclusivities

API Supply Chain16 active DMFs13 inactive

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

LUPIN LTDCEFUROXIME AXETIL (CRYSTALLINE) USP

DMF 147692000

LUPIN LTDCEFUROXIME AXETIL (AMORPHOUS) USP

DMF 161082002

WOCKHARDT LTDCEFUROXIME AXETIL (AMORPHOUS)

DMF 162672002

APITORIA PHARMA PRIVATE LTDCEFUROXIME AXETIL USP

DMF 177072004

UNIMARK REMEDIES LTDCEFUROXIME AXETIL USP

DMF 205452007

PURE AND CURE HEALTHCARE PRIVATE LIMITEDCEFUROXIME AXETIL USP (CRYSTALLINE)

DMF 216152008

PURE AND CURE HEALTHCARE PRIVATE LTDCEFUROXIME AXETIL USP (AMORPHOUS)

DMF 216712008

NECTAR LIFESCIENCES LTDCEFUROXIME AXETIL USP (CRYSTALLINE)

DMF 223272008

NECTAR LIFESCIENCES LTDCEFUROXIME AXETIL USP (AMORPHOUS)

DMF 224262009

PURE AND CURE HEALTHCARE PRIVATE LTDCEFUROXIME AXETIL CRYSTALLINE ( PROCESS-II )

DMF 234532010

PURE AND CURE HEALTHCARE PRIVATE LTDCEFUROXIME AXETIL (AMORPHOUS) PROCESS II USP

DMF 236962010

ORCHID PHARMA LTDCEFUROXIME AXETIL (CRYSTALLINE) (NON-STERILE BULK API)

DMF 238912010

PURE AND CURE HEALTHCARE PRIVATE LTDCEFUROXIME AXETIL - AMORPHOUS (PROCESS-III) USP

DMF 245372011

PURE AND CURE HEALTHCARE PRIVATE LTDCEFUROXIME AXETIL (CRYSTALLINE) PROCESS-III

DMF 245842011

COVALENT LABORATORIES PRIVATE LTDCEFUROXIME AXETIL USP (AMORPHOUS)

DMF 250752011

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDCEFUROXIME AXETIL

DMF 361982021

FARMABIOS SRLInactiveCEFUROXIME

DMF 140101999

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCEFUROXIME AXETIL USP (CRYSTALLINE)

DMF 140581999

RANBAXY LABORATORIES LTDInactiveCEFUROXIME AXETIL

DMF 140741999

FAKO ILACLARI ASInactiveCEFUROXIME AXETIL AMORPHOUS

DMF 146532000

GLAXO WELLCOME INCInactiveCEFUROXIME AXETIL BULK DRUG SUBSTANCE

DMF 149922000

ACS DOBFAR SPAInactiveCEFUROXIME FOR INJECTION (75G AND 225G BULK PACKS)

DMF 152342001

WOCKHARDT LTDInactiveCEFUROXIME AXETIL (AMORPHOUS)

DMF 154512001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCEFUROXIME AXETIL USP

DMF 157952001

SANDOZ PRIVATE LTDInactiveCEFUROXIME AXETIL

DMF 158152002

OLON SPAInactiveCEFUROXIME AXETIL

DMF 163502003

NECTAR LIFESCIENCES LTDInactiveCEFUROXIME AXETIL AMORPHOUS USP

DMF 195702006

TITAN PHARMACEUTICAL CO LTD GUANGDONGInactiveCEFUROXIME AXETIL DRUG SUBSTANCE

DMF 207502007

COVALENT LABORATORIES PRIVATE LTDInactiveCEFUROXIME AXETIL USP (CRYSTALLINE)

DMF 232372009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 15, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 500MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 15, 2002

No patent or exclusivity listings for this strength.

#002 — EQ 250MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 15, 2002

#003 — EQ 125MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 15, 2002