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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 two suppliers. There are two patents 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. 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: 021277

Tradename:
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Applicant:
Bayer Hlthcare
Ingredient:
moxifloxacin hydrochloride
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021277

Ingredient-typeQuinolones

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;IV (INFUSION) 021277 NDA Schering Plough Corporation 0085-1737 0085-1737-01 250 mL in 1 BAG (0085-1737-01)
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
moxifloxacin hydrochloride
SOLUTION;IV (INFUSION) 021277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-537 50419-537-01 250 mL in 1 BAG (50419-537-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength400MG/250ML (1.6MG/ML)
Approval Date:Nov 30, 2001TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 27, 2019
Regulatory Exclusivity Use:
Patent:5,849,752Patent Expiration:Dec 5, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT
Patent:6,548,079Patent Expiration:Jul 25, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT

Expired Orange Book 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;IV (INFUSION)021277-001Nov 30, 20014,990,517► subscribe
Bayer Hlthcare
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
moxifloxacin hydrochloride
SOLUTION;IV (INFUSION)021277-001Nov 30, 20015,849,752► subscribe
Bayer Hlthcare
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
moxifloxacin hydrochloride
SOLUTION;IV (INFUSION)021277-001Nov 30, 20015,607,942► subscribe
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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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