Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078024
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 200MG/100ML INJECTABLE;INJECTION Prescription AP No No
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
03/18/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078024s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/06/2019 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/06/2019 SUPPL-29 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/18/2018 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/15/2018 SUPPL-21 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/27/2017 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/27/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

06/07/2016 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/07/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

06/07/2016 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2012 SUPPL-9 Labeling-Medication Guide, REMS-Modified

Label is not available on this site.

05/21/2012 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/16/2011 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/26/2010 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

05/26/2009 SUPPL-3 Labeling

Label is not available on this site.

01/29/2009 SUPPL-2 Labeling

Label is not available on this site.

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200MG/100ML
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 200MG/100ML INJECTABLE;INJECTION Prescription No AP 078024 BAXTER HLTHCARE CORP
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 200MG/100ML INJECTABLE;INJECTION Prescription No AP 077753 HOSPIRA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 200MG/100ML INJECTABLE;INJECTION Prescription No AP 078252 INFORLIFE

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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