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Generated: May 22, 2017

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Details for New Drug Application (NDA): 200160

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NDA 200160 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Watson Labs Inc, Aurobindo Pharma Ltd, Mylan Pharms Inc, Teva Pharms Usa, Dr Reddys Labs Ltd, Crossmedika Sa, Torrent Pharms Ltd, Lupin Ltd, Fresenius Kabi Usa, Novel Labs Inc, and Mylan Labs Ltd, and is included in twelve NDAs. It is available from eleven 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-four suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for NDA: 200160

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 200160


Suppliers and Packaging for NDA: 200160

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
moxifloxacin hydrochloride
TABLET;ORAL 200160 ANDA TORRENT PHARMACEUTICALS LIMITED 13668-201 13668-201-01 100 TABLET in 1 BOTTLE (13668-201-01)
moxifloxacin hydrochloride
TABLET;ORAL 200160 ANDA TORRENT PHARMACEUTICALS LIMITED 13668-201 13668-201-05 500 TABLET in 1 BOTTLE (13668-201-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Apr 3, 2014TE:ABRLD:No

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