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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 200160


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NDA 200160 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Indoco, Lupin Ltd, Mylan, Upsher Smith Labs, Fresenius Kabi Usa, Aurobindo Pharma Ltd, Chartwell Rx, Crossmedika Sa, Dr Reddys, Hetero Labs Ltd V, MSN, Sunshine, Teva Pharms Usa, Torrent, and Mylan Labs Ltd, and is included in twenty-two NDAs. It is available from thirty-one 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-four suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 200160
Tradename:MOXIFLOXACIN HYDROCHLORIDE
Applicant:Torrent
Ingredient:moxifloxacin hydrochloride
Patents:0
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 moxifloxacin hydrochloride TABLET;ORAL 200160 ANDA Torrent Pharmaceuticals Limited 13668-201 13668-201-01 100 TABLET in 1 BOTTLE (13668-201-01)
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 200160 ANDA Torrent Pharmaceuticals Limited 13668-201 13668-201-05 500 TABLET in 1 BOTTLE (13668-201-05)

Profile for product number 001

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

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