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Serving leading biopharmaceutical companies globally:

Teva
Cerilliant
McKesson
Medtronic
Citi
Dow
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Federal Trade Commission
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Generated: October 20, 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 Rising Pharms Inc, Orchid Hlthcare, Hetero Labs Ltd V, Dr Reddys Labs Inc, Jubilant Generics, Torrent Pharms, Lupin, Watson Labs Teva, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Sandoz, Macleods Pharms Ltd, Akorn, Glenmark Generics, Zydus Pharms Usa Inc, Sagent Agila Llc, 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-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 NDA: 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
QuintilesIMS
Daiichi Sankyo
Healthtrust
Chubb
Mallinckrodt
Cerilliant
Argus Health
McKinsey
AstraZeneca

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