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US Department of Justice

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202632

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NDA 202632 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 nineteen 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. Thirty-two suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 202632
Tradename:MOXIFLOXACIN HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:moxifloxacin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 202632
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 202632
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 202632 ANDA AvPAK 50268-576 N 50268-576-13
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 202632 ANDA Rising Health, LLC 57237-156 N 57237-156-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Mar 4, 2014TE:ABRLD:No

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