CEFEPIME HYDROCHLORIDE از شرکت QILU

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CEFEPIME HYDROCHLORIDE از شرکت QILU

Abbreviated New Drug Application (ANDA): 203704

Company: QILU

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription

AP

No No
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription

AP

No No
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE 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
02/01/2016 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
02/11/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/15/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/15/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

CEFEPIME HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL

TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203704 QILU
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050679 HOSPIRA INC

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
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065441 ACS DOBFAR
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203704 QILU
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091048 SAGENT PHARMS INC
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050679 HOSPIRA INC

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
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065441 ACS DOBFAR
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203704 QILU
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091048 SAGENT PHARMS INC
MAXIPIME CEFEPIME HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050679 HOSPIRA INC
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