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Serving leading biopharmaceutical companies globally:

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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200674

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NDA 200674 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 200674

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

Suppliers and Packaging for NDA: 200674

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION 200674 ANDA Fresenius Kabi USA, LLC 63323-355 63323-355-50 1 BAG in 1 POUCH (63323-355-50) > 50 mL in 1 BAG
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION 200674 ANDA Fresenius Kabi USA, LLC 63323-355 63323-355-60 1 BAG in 1 POUCH (63323-355-60) > 150 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG/50ML (EQ 5MG/ML)
Approval Date:Jun 19, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/100ML (EQ 5MG/ML)
Approval Date:Jun 19, 2013TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/150ML (EQ 5MG/ML)
Approval Date:Jun 19, 2013TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
Citi
UBS
US Army
Baxter
Fuji
QuintilesIMS
Healthtrust
Daiichi Sankyo
Accenture

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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