Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065051
Company: HIKMA
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 No
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/11/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65051ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2003 SUPPL-1 Labeling

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 065051 HIKMA
CEFOXITIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065238 HIKMA FARMACEUTICA
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 065051 HIKMA
CEFOXITIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065238 HIKMA FARMACEUTICA
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 065214 B BRAUN

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