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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

Tradename:
BROMDAY
Applicant:
Bausch And Lomb Inc
Ingredient:
bromfenac sodium
Patents:0
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
BROMDAY
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)
BROMDAY
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0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb Inc
XIBROM
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC021664-001Mar 24, 20054,910,225► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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