Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065414
Company: ACS DOBFAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/12/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CEFOXITIN

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065414 ACS DOBFAR
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065238 HIKMA FARMACEUTICA
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065051 WEST-WARD PHARMS INT
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 065214 B BRAUN

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065414 ACS DOBFAR
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065238 HIKMA FARMACEUTICA
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065051 WEST-WARD PHARMS INT
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 065214 B BRAUN

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