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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Novartis
Healthtrust
UBS
US Army
Covington
Boehringer Ingelheim
QuintilesIMS
Dow
AstraZeneca

Generated: July 25, 2017

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 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, Apotex Inc, Novel Labs Inc, and Mylan Labs Ltd, and is included in thirteen NDAs. It is available from thirteen 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-seven suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for NDA: 205348

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 205348

Ingredient-typeQuinolones

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 Breckenridge Pharmaceutical, Inc. 51991-943 51991-943-33 30 TABLET in 1 BOTTLE (51991-943-33)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Jan 14, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cipla
Harvard Business School
Dow
Argus Health
Farmers Insurance
Express Scripts
Queensland Health
Cerilliant
Fish and Richardson
Novartis

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