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Generated: November 21, 2018

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Details for New Drug Application (NDA): 200674

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NDA 200674 describes LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, and Inforlife, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are thirty drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 200674
Tradename:LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:levofloxacin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200674
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674 ANDA Fresenius Kabi USA, LLC 63323-355 63323-355-50 1 BAG in 1 POUCH (63323-355-50) > 50 mL in 1 BAG
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674 ANDA Fresenius Kabi USA, LLC 63323-355 63323-355-60 1 BAG in 1 POUCH (63323-355-60) > 150 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG/50ML (EQ 5MG/ML)
Approval Date:Jun 19, 2013TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/100ML (EQ 5MG/ML)
Approval Date:Jun 19, 2013TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/150ML (EQ 5MG/ML)
Approval Date:Jun 19, 2013TE:APRLD:No

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