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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving leading biopharmaceutical companies globally:

Accenture
Medtronic
Teva
Healthtrust
Chinese Patent Office
Cerilliant
Daiichi Sankyo
Mallinckrodt
Colorcon
Chubb

Generated: November 23, 2017

DrugPatentWatch Database Preview

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 Baxter Hlthcare Corp, and is included in six NDAs. It is available from eight 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-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 091397

Tradename:
1
Applicant:
1
Ingredient:
1
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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Accenture
US Army
Novartis
Mallinckrodt
Fish and Richardson
Queensland Health
Cantor Fitzgerald
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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