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Details for New Drug Application (NDA): 206919

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NDA 206919 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: 206919

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

Suppliers and Packaging for NDA: 206919

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION 206919 ANDA AuroMedics Pharma LLC 55150-243 55150-243-46 24 POUCH in 1 CARTON (55150-243-46) > 1 BAG in 1 POUCH > 50 mL in 1 BAG
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION 206919 ANDA AuroMedics Pharma LLC 55150-244 55150-244-47 24 POUCH in 1 CARTON (55150-244-47) > 1 BAG in 1 POUCH > 100 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG/50ML (EQ 5MG/ML)
Approval Date:Feb 10, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/100ML (EQ 5MG/ML)
Approval Date:Feb 10, 2016TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/150ML (EQ 5MG/ML)
Approval Date:Feb 10, 2016TE:APRLD:No


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