Details for New Drug Application (NDA): 022288

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NDA 022288 describes BEPREVE, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the BEPREVE profile page.

The generic ingredient in BEPREVE is bepotastine besilate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bepotastine besilate profile page.

Summary for 022288

Tradename:	BEPREVE
Applicant:	Bausch And Lomb Inc
Ingredient:	bepotastine besilate
Patents:	1

Pharmacology for NDA: 022288

Suppliers and Packaging for NDA: 022288

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288	NDA	Bausch & Lomb Incorporated	24208-629	24208-629-01	1 BOTTLE, DROPPER in 1 CARTON (24208-629-01) / 10 mL in 1 BOTTLE, DROPPER
BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288	NDA	Bausch & Lomb Incorporated	24208-629	24208-629-02	1 BOTTLE, DROPPER in 1 CARTON (24208-629-02) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1.5%
Approval Date:	Sep 8, 2009	TE:	AT	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jan 13, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022288

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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