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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, and Fresenius Kabi Usa, and is included in ten NDAs. It is available from ten 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-three suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for NDA: 200160

Tradename:
MOXIFLOXACIN HYDROCHLORIDE
Applicant:
Torrent Pharms Ltd
Ingredient:
moxifloxacin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 200160

Ingredient-typeQuinolones

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)

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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