Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209218
Company: QILU PHARM CO LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM 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
10/17/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CEFTRIAXONE

INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065328 ACS DOBFAR
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065232 HOSPIRA INC
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 209218 QILU PHARM CO LTD
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065168 SANDOZ
CEFTRIAXONE SODIUM CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091117 ASTRAL
CEFTRIAXONE SODIUM CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090701 HIKMA

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