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Fish and Richardson
Citi
Cerilliant
Fuji
UBS
Boehringer Ingelheim
Queensland Health
Baxter
Cipla
Colorcon

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020635

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NDA 020635 describes LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are twenty-nine drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for 020635

Tradename:2
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020635

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635 NDA Janssen Pharmaceuticals, Inc. 50458-166 50458-166-01 150 mL in 1 BAG (50458-166-01)
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635 NDA Janssen Pharmaceuticals, Inc. 50458-166 50458-166-01 150 mL in 1 BAG (50458-166-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/20ML (EQ 25MG/ML)
Approval Date:Dec 20, 1996TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 20, 1996TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 20, 1996TE:RLD:Yes

Expired Orange Book Patents for NDA: 020635

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsLEVAQUINlevofloxacinINJECTABLE;INJECTION020635-001Dec 20, 1996► Subscribe► Subscribe
Janssen PharmsLEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERlevofloxacinINJECTABLE;INJECTION020635-002Dec 20, 1996► Subscribe► Subscribe
Janssen PharmsLEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERlevofloxacinINJECTABLE;INJECTION020635-003Dec 20, 1996► Subscribe► Subscribe
Janssen PharmsLEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERlevofloxacinINJECTABLE;INJECTION020635-002Dec 20, 1996► Subscribe► Subscribe
Janssen PharmsLEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERlevofloxacinINJECTABLE;INJECTION020635-003Dec 20, 1996► Subscribe► Subscribe
Janssen PharmsLEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERlevofloxacinINJECTABLE;INJECTION020635-005Dec 20, 1996► Subscribe► Subscribe
Janssen PharmsLEVAQUINlevofloxacinINJECTABLE;INJECTION020635-004Dec 20, 1996► Subscribe► Subscribe
Janssen PharmsLEVAQUINlevofloxacinINJECTABLE;INJECTION020635-001Dec 20, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
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