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Last Updated: December 8, 2019

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Details for New Drug Application (NDA): 021277

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NDA 021277 describes AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER profile page.

The generic ingredient in AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 021277
Tradename:AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Applicant:Bayer Hlthcare
Ingredient:moxifloxacin hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021277
Suppliers and Packaging for NDA: 021277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-537 50419-537-01 250 mL in 1 BAG (50419-537-01)
Paragraph IV (Patent) Challenges for 021277
Tradename Dosage Ingredient NDA Submissiondate
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER SOLUTION;INTRAVENOUS moxifloxacin hydrochloride 021277 2014-02-07

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 30, 2001TE: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:  Start TrialPatent Expiration:Jul 25, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT

Expired US Patents for NDA 021277

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001   Start Trial   Start Trial
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001   Start Trial   Start Trial
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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