Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078062
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN CIPROFLOXACIN 200MG/20ML (10MG/ML) INJECTABLE;INJECTION Prescription AP No Yes
CIPROFLOXACIN CIPROFLOXACIN 400MG/40ML (10MG/ML) 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
04/29/2008 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
05/06/2019 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/06/2019 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/18/2018 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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

Label is not available on this site.

01/27/2017 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/27/2017 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/07/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/07/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

06/07/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2012 SUPPL-8 Labeling-Medication Guide, REMS-Modified

Label is not available on this site.

05/24/2012 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/16/2011 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/29/2010 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

05/26/2009 SUPPL-2 Labeling

Label is not available on this site.

01/29/2009 SUPPL-1 Labeling

Label is not available on this site.

CIPROFLOXACIN

INJECTABLE;INJECTION; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPROFLOXACIN CIPROFLOXACIN 200MG/20ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 078062 BAXTER HLTHCARE CORP
CIPROFLOXACIN CIPROFLOXACIN 200MG/20ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 076717 HIKMA FARMACEUTICA
CIPROFLOXACIN CIPROFLOXACIN 200MG/20ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 077245 HOSPIRA

INJECTABLE;INJECTION; 400MG/40ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPROFLOXACIN CIPROFLOXACIN 400MG/40ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 078062 BAXTER HLTHCARE CORP
CIPROFLOXACIN CIPROFLOXACIN 400MG/40ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 076717 HIKMA FARMACEUTICA
CIPROFLOXACIN CIPROFLOXACIN 400MG/40ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 077245 HOSPIRA

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