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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 Alcon Pharms Ltd 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. 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: 021598

Tradename:
VIGAMOX
Applicant:
Alcon Pharms Ltd
Ingredient:
moxifloxacin hydrochloride
Patents:2
Therapeutic Class:Antibacterials
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Apr 15, 2003TE:AT1RLD:Yes
Patent:6,716,830*PEDPatent Expiration:Mar 29, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:7,671,070*PEDPatent Expiration:Mar 29, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021598

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
VIGAMOX
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC021598-001Apr 15, 20034,990,517*PED► subscribe
Alcon Pharms Ltd
VIGAMOX
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC021598-001Apr 15, 20035,607,942*PED► subscribe
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