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Last Updated: November 22, 2024

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 Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Inforlife, and Knack, and is included in eight NDAs. It is available from nine 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-one drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 091397
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 Baxter Healthcare Corporation 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 Baxter Healthcare Corporation 36000-047 36000-047-24 100 mL in 1 BAG (36000-047-24)

Profile for product number 001

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

Profile for product number 002

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

Profile 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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