Details for New Drug Application (NDA): 021598

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NDA 021598 describes VIGAMOX, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from three suppliers. 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-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for 021598

Tradename:	VIGAMOX
Applicant:	Harrow Eye
Ingredient:	moxifloxacin hydrochloride
Patents:	0

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	Novartis Pharmaceuticals Corporation	0078-0939	0078-0939-26	1 BOTTLE in 1 CARTON (0078-0939-26) / 3 mL in 1 BOTTLE
VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7135	0781-7135-93	1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Apr 15, 2003	TE:	AT1	RLD:	Yes

Expired US Patents for NDA 021598

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	7,671,070*PED	⤷ Subscribe
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	4,990,517*PED	⤷ Subscribe
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	6,716,830*PED	⤷ Subscribe
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	5,849,752*PED	⤷ Subscribe
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	5,607,942*PED	⤷ Subscribe
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