Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065374
Company: FRESENIUS KABI USA
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 Yes
CEFOTETAN CEFOTETAN DISODIUM 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
08/09/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065374ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/27/2018 SUPPL-4 Labeling-Package Insert

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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