Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078431
Company: HIKMA FARMACEUTICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 400MG/200ML 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
11/18/2009 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
05/03/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/16/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/15/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/15/2018 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/25/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/07/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 400MG/200ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 400MG/200ML INJECTABLE;INJECTION Prescription No AP 078024 BAXTER HLTHCARE CORP
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 400MG/200ML INJECTABLE;INJECTION Prescription No AP 078431 HIKMA FARMACEUTICA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 400MG/200ML INJECTABLE;INJECTION Prescription No AP 077753 HOSPIRA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 400MG/200ML INJECTABLE;INJECTION Prescription No AP 078252 INFORLIFE

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