Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091031
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFOTETAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
CEFOTETAN CEFOTETAN DISODIUM 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
10/26/2011 ORIG-1 Approval

Label is not available on this site.

CEFOTETAN

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
CEFOTAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050588 TELIGENT
CEFOTETAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065374 FRESENIUS KABI USA
CEFOTETAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091031 HIKMA

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
CEFOTAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050588 TELIGENT
CEFOTETAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065374 FRESENIUS KABI USA
CEFOTETAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091031 HIKMA

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