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Generated: May 27, 2019

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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 and one Paragraph IV challenge. Additional details are available on the BROMSITE profile page.

The generic ingredient in BROMSITE is bromfenac sodium. Four suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 206911
Tradename:BROMSITE
Applicant:Sun Pharma Global
Ingredient:bromfenac sodium
Patents:1
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

Profile 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:➤ Try a Free TrialPatent Expiration:Aug 7, 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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