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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021598

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NDA 021598 describes VIGAMOX, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from five 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. Thirty-four suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 021598
Tradename:VIGAMOX
Applicant:Novartis Pharms Corp
Ingredient:moxifloxacin hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021598
Ingredient-typeQuinolones
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

Profile for product number 001

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

Expired US Patents for NDA 021598

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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