Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091397
Company: BAXTER HLTHCARE CORP
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
08/08/2013 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-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/06/2019 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

10/15/2018 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/23/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/20/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/23/2014 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Medication Guide, 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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