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Last Updated: November 28, 2021

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, Alembic Pharms Ltd, Apotex, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Mylan, Upsher Smith Labs, Watson Labs Inc, Fresenius Kabi Usa, Aurobindo Pharma Ltd, Crossmedika Sa, Dr Reddys Labs Ltd, MSN, Novel Labs Inc, Sunshine, Teva Pharms Usa, Torrent, and Mylan Labs Ltd, and is included in twenty-one NDAs. It is available from twenty-six 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 suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 205348
Applicant:Crossmedika Sa
Ingredient:moxifloxacin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 205348
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 A-S Medication Solutions 50090-4058 50090-4058-1 30 TABLET in 1 BOTTLE (50090-4058-1)
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 205348 ANDA A-S Medication Solutions 50090-4100 50090-4100-0 10 TABLET in 1 BOTTLE (50090-4100-0)

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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