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Details for New Drug Application (NDA): 091397

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NDA 091397 describes LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Aurobindo Pharma Ltd, Acs Dobfar Info Sa, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira Inc, and Claris, 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 twenty-eight drug master file entries for this compound. Sixty suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the levofloxacin profile page.

Summary for NDA: 091397

Tradename:
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:
Claris
Ingredient:
levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 091397

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION 091397 ANDA Claris Lifesciences Inc. 36000-046 36000-046-24 50 mL in 1 BAG (36000-046-24)
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION 091397 ANDA Claris Lifesciences Inc. 36000-047 36000-047-24 100 mL in 1 BAG (36000-047-24)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG/50ML (EQ 5MG/ML)
Approval Date:Aug 8, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/100ML (EQ 5MG/ML)
Approval Date:Aug 8, 2013TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/150ML (EQ 5MG/ML)
Approval Date:Aug 8, 2013TE:APRLD:No


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