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Generated: October 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021085

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NDA 021085 describes AVELOX, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from seven suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AVELOX profile page.

The generic ingredient in AVELOX 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 021085
Tradename:AVELOX
Applicant:Bayer Hlthcare
Ingredient:moxifloxacin hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021085
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 021085
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085 NDA Schering Plough Corporation 0085-1733 0085-1733-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0085-1733-01)
AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085 NDA Schering Plough Corporation 0085-1733 0085-1733-02 50 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0085-1733-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Dec 10, 1999TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Sep 27, 2019
Regulatory Exclusivity Use:UPDATES TO THE LABELING TO INCLUDE RESULTS OF A TRIAL TO EVALUATE THE SAFETY OF MOXIFLOXACIN IN PEDIATRIC PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTIONS
Patent:➤ Sign UpPatent Expiration:Oct 29, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT

Expired US Patents for NDA 021085

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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McKinsey
Colorcon
Chubb
Covington
Mallinckrodt
US Department of Justice
Dow
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Deloitte

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