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Generated: June 23, 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 eight 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-three 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
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021085

Ingredient-type	Quinolones

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	N	0085-1733-01
AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085	NDA	Schering Plough Corporation	0085-1733	N	0085-1733-02

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Dec 10, 1999	TE:	AB	RLD:	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 Up	Patent Expiration:	Oct 29, 2019	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF COMBATING BACTERIA IN A PATIENT

Expired US Patents for NDA 021085

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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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