Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200674
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription AP No No
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription AP No No
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/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
06/19/2013 ORIG-1 Approval Not Applicable

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-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/18/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/24/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 250MG/50ML (EQ 5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 206919 AUROBINDO PHARMA LTD
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 091397 BAXTER HLTHCARE CORP
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 200674 FRESENIUS KABI USA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 091375 HIKMA FARMACEUTICA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 078579 HOSPIRA INC
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 090343 INFORLIFE

INJECTABLE;INJECTION; EQ 500MG/100ML (EQ 5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 206919 AUROBINDO PHARMA LTD
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 091397 BAXTER HLTHCARE CORP
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 200674 FRESENIUS KABI USA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 091375 HIKMA FARMACEUTICA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 078579 HOSPIRA INC
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 090343 INFORLIFE

INJECTABLE;INJECTION; EQ 750MG/150ML (EQ 5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 206919 AUROBINDO PHARMA LTD
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 091397 BAXTER HLTHCARE CORP
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 200674 FRESENIUS KABI USA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 091375 HIKMA FARMACEUTICA
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 078579 HOSPIRA INC
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE;INJECTION Prescription No AP 090343 INFORLIFE

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