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Details for New Drug Application (NDA): 021664

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NDA 021664 describes XIBROM, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the XIBROM profile page.

The generic ingredient in XIBROM is bromfenac sodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

Summary for NDA: 021664

Bausch And Lomb Inc
bromfenac sodium
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 021664

Suppliers and Packaging for NDA: 021664

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC 021664 NDA Unit Dose Services 50436-6301 50436-6301-0 1.7 mL in 1 BOTTLE, DROPPER (50436-6301-0)
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC 021664 NDA Physicians Total Care, Inc. 54868-6301 54868-6301-0 1 BOTTLE, DROPPER in 1 CARTON (54868-6301-0) > 1.7 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.09% ACID
Approval Date:Mar 24, 2005TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 16, 2010TE:RLD:No

Expired Orange Book Patents for NDA: 021664

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb Inc
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC021664-001Mar 24, 20054,910,225<disabled>
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