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Details for New Drug Application (NDA): 022308

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NDA 022308 describes BESIVANCE, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from three suppliers. There are seven patents protecting this drug. Additional details are available on the BESIVANCE profile page.

The generic ingredient in BESIVANCE is besifloxacin hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the besifloxacin hydrochloride profile page.

Summary for NDA: 022308

Tradename:
BESIVANCE
Applicant:
Bausch And Lomb
Ingredient:
besifloxacin hydrochloride
Patents:7

Pharmacology for NDA: 022308

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 022308

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC 022308 NDA Bausch & Lomb Incorporated 24208-446 24208-446-02 1 BOTTLE, DROPPER in 1 CARTON (24208-446-02) > 2 mL in 1 BOTTLE, DROPPER
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC 022308 NDA Bausch & Lomb Incorporated 24208-446 24208-446-05 1 BOTTLE, DROPPER in 1 CARTON (24208-446-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrengthEQ 0.6% BASE
Approval Date:May 28, 2009TE:RLD:Yes
Patent:8,481,526Patent Expiration:Jan 9, 2031Product Flag?Substance Flag?YDelist Request?
Patent:8,604,020Patent Expiration:Mar 12, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:5,447,926Patent Expiration:Apr 13, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING OCULAR BACTERIAL INFECTIONS

Expired Orange Book Patents for NDA: 022308

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 20095,447,926► 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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