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Generated: December 15, 2017

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 seventeen 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-three suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for 202632

Tradename:1
Applicant:1
Ingredient:1
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 50268-576-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-576-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-576-11)
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 202632 ANDA Citron Pharma LLC 57237-156 57237-156-30 30 TABLET, FILM COATED in 1 BOTTLE (57237-156-30)

Summary for product number 001

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


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