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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 021598


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NDA 021598 describes VIGAMOX, which is a drug marketed by Novartis and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VIGAMOX profile page.

The generic ingredient in VIGAMOX is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 021598
Tradename:VIGAMOX
Applicant:Novartis
Ingredient:moxifloxacin hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021598
Suppliers and Packaging for NDA: 021598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598 NDA Alcon Laboratories, Inc. 0065-4013 0065-4013-01 1 BOTTLE in 1 CARTON (0065-4013-01) > 1 mL in 1 BOTTLE
VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598 NDA Alcon Laboratories, Inc. 0065-4013 0065-4013-03 1 BOTTLE, PLASTIC in 1 CARTON (0065-4013-03) > 3 mL in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 021598
Tradename Dosage Ingredient NDA Submissiondate
VIGAMOX SOLUTION/DROPS;OPHTHALMIC moxifloxacin hydrochloride 021598 2005-12-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Apr 15, 2003TE:AT1RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 29, 2020Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 29, 2020Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021598

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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