Details for New Drug Application (NDA): 206911
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NDA 206911 describes BROMSITE, which is a drug marketed by Sun Pharm 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. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
The generic ingredient in BROMSITE is bromfenac sodium. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 206911
| Tradename: | BROMSITE |
| Applicant: | Sun Pharm |
| Ingredient: | bromfenac sodium |
| Patents: | 1 |
Pharmacology for NDA: 206911
| Mechanism of Action | Cyclooxygenase Inhibitors |
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 |
| BROMSITE | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 206911 | NDA AUTHORIZED GENERIC | Sun Pharmaceutical Industries, Inc. | 49708-755 | 49708-755-41 | 1 POUCH in 1 CARTON (49708-755-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.075% ACID | ||||
| Approval Date: | Apr 8, 2016 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Aug 7, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY | ||||||||
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