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Serving leading biopharmaceutical companies globally:

McKinsey
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US Army
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200560

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NDA 200560 describes LEVOFLOXACIN, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Hospira Inc, Sagent Agila Llc, Zydus Pharms Usa Inc, Apotex Inc, Rising Pharms Inc, Watson Labs Teva, Hi Tech Pharma, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Wockhardt, Acs Dobfar Info Sa, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in thirty-six NDAs. It is available from fifty-eight suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN 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 200560

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

Suppliers and Packaging for NDA: 200560

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 200560 ANDA Sagent Pharmaceuticals 25021-130 25021-130-20 1 VIAL in 1 CARTON (25021-130-20) > 20 mL in 1 VIAL
LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 200560 ANDA Sagent Pharmaceuticals 25021-130 25021-130-30 1 VIAL in 1 CARTON (25021-130-30) > 30 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG/20ML (EQ 25MG/ML)
Approval Date:Jun 20, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 750MG/30ML (EQ 25MG/ML)
Approval Date:Jun 20, 2011TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
McKinsey
Fish and Richardson
Deloitte
US Army
Chubb
Harvard Business School
Fuji
Queensland Health

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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