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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076938

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NDA 076938 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 076938
Tradename:MOXIFLOXACIN HYDROCHLORIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:moxifloxacin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 076938
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 076938
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 076938 ANDA Major Pharmaceuticals 0904-6406 N 0904-6406-06
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 076938 ANDA Dr. Reddy's Laboratories Limited 55111-112 N 55111-112-01

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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