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Generated: November 21, 2018

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Details for New Drug Application (NDA): 091375

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NDA 091375 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 091375
Tradename:LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Hikma Farmaceutica
Ingredient:levofloxacin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091375
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA West-Ward Pharmaceuticals Corp 0143-9315 0143-9315-24 24 BAG in 1 CARTON (0143-9315-24) > 50 mL in 1 BAG (0143-9315-01)
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091375 ANDA West-Ward Pharmaceuticals Corp 0143-9316 0143-9316-24 24 BAG in 1 CARTON (0143-9316-24) > 100 mL in 1 BAG (0143-9316-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG/50ML (EQ 5MG/ML)
Approval Date:Sep 16, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/100ML (EQ 5MG/ML)
Approval Date:Sep 16, 2011TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/150ML (EQ 5MG/ML)
Approval Date:Sep 16, 2011TE:APRLD:No

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