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US Department of Justice
Dow
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Cantor Fitzgerald
US Army
Boehringer Ingelheim
Citi
Covington
Deloitte

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205348

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NDA 205348 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Akorn, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Watson Labs Inc, Fresenius Kabi Usa, Crossmedika Sa, Dr Reddys Labs Ltd, Msn Labs Pvt Ltd, Mylan Pharms Inc, Novel Labs Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Mylan Labs Ltd, and is included in sixteen NDAs. It is available from eighteen suppliers. Additional details are available on the MOXIFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 205348
Tradename:MOXIFLOXACIN HYDROCHLORIDE
Applicant:Crossmedika Sa
Ingredient:moxifloxacin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 205348
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 205348
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 205348 ANDA Breckenridge Pharmaceutical, Inc. 51991-943 N 51991-943-33
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 205348 ANDA Golden State Medical Supply, Inc. 60429-893 N 60429-893-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Jan 14, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
QuintilesIMS
Daiichi Sankyo
Teva
Moodys
McKesson
UBS
Mallinckrodt

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