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Details for New Drug Application (NDA): 206911

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NDA 206911 describes BROMSITE, which is a drug marketed by Sun Pharma Global and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the BROMSITE profile page.

The generic ingredient in BROMSITE 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: 206911

Tradename:
BROMSITE
Applicant:
Sun Pharma Global
Ingredient:
bromfenac sodium
Patents:1
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 206911

Suppliers and Packaging for NDA: 206911

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMSITE
bromfenac sodium
SOLUTION/DROPS;OPHTHALMIC 206911 NDA Sun Pharmaceutical Industries, Inc. 49708-754 49708-754-41 1 POUCH in 1 CARTON (49708-754-41) > 1 BOTTLE, DROPPER in 1 POUCH > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.075% ACID
Approval Date:Apr 8, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 8, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:8,778,999Patent Expiration:Sep 3, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY


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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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