Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077245
Company: HOSPIRA
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 No
CIPROFLOXACIN CIPROFLOXACIN 400MG/40ML (10MG/ML) 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
08/28/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077245s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-23 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/15/2018 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

10/15/2018 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/05/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

06/27/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

03/08/2012 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

06/23/2011 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/19/2009 SUPPL-10 Labeling

Label is not available on this site.

01/14/2009 SUPPL-8 Labeling

Label is not available on this site.

07/22/2008 SUPPL-6 Labeling

Label is not available on this site.

10/05/2007 SUPPL-4 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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