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Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076361

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NDA 076361 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: 076361

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

Pharmacology for NDA: 076361

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 076361

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOFLOXACIN
levofloxacin
TABLET;ORAL 076361 ANDA STAT RX USA LLC 16590-992 16590-992-07 7 TABLET, FILM COATED in 1 BOTTLE (16590-992-07)
LEVOFLOXACIN
levofloxacin
TABLET;ORAL 076361 ANDA STAT RX USA LLC 16590-992 16590-992-10 10 TABLET, FILM COATED in 1 BOTTLE (16590-992-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 20, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jun 20, 2011TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
Farmers Insurance
Merck
Moodys
Julphar
Express Scripts
Colorcon
Harvard Business School
Accenture

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