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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091678

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NDA 091678 describes LEVOFLOXACIN, which is a drug marketed by Rising Pharms Inc, Orchid Hlthcare, Hetero Labs Ltd V, Dr Reddys Labs Inc, Jubilant Generics, Torrent Pharms, Lupin, Watson Labs Teva, Aurobindo Pharma Ltd, Claris, Sandoz, Macleods Pharms Ltd, Akorn, Glenmark Generics, Zydus Pharms Usa Inc, Sagent Pharms, Teva, Wockhardt, Mylan, Hospira Inc, Hi Tech Pharma, Apotex Inc, Watson Labs Inc, Emcure Pharms Ltd, Cipla Ltd, Acs Dobfar Info Sa, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in thirty-six NDAs. It is available from fifty-six suppliers. Additional details are available on the LEVOFLOXACIN profile page.

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are twenty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for NDA: 091678

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

Suppliers and Packaging for NDA: 091678

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN
levofloxacin
SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286 50383-286-04 1 BOTTLE in 1 CARTON (50383-286-04) > 100 mL in 1 BOTTLE
LEVOFLOXACIN
levofloxacin
SOLUTION;ORAL 091678 ANDA Hi-Tech Pharmacal Co., Inc. 50383-286 50383-286-08 1 BOTTLE in 1 CARTON (50383-286-08) > 200 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/10ML
Approval Date:Jun 20, 2011TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Accenture
McKinsey
US Army
Boehringer Ingelheim
Argus Health
UBS
Express Scripts
Queensland Health
Chubb
US Department of Justice

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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