Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077753
Company: HOSPIRA
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 Yes
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER CIPROFLOXACIN 400MG/200ML 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
03/18/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077753s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/15/2018 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

05/05/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

06/27/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

03/15/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/26/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/15/2009 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/19/2009 SUPPL-3 Labeling

Label is not available on this site.

01/14/2009 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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