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Generated: November 13, 2018

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Details for New Drug Application (NDA): 209310

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NDA 209310 describes SINUVA, which is a drug marketed by Intersect Ent Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the SINUVA profile page.

The generic ingredient in SINUVA is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 209310
Tradename:SINUVA
Applicant:Intersect Ent Inc
Ingredient:mometasone furoate
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 209310
Medical Subject Heading (MeSH) Categories for 209310
Suppliers and Packaging for NDA: 209310
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SINUVA mometasone furoate IMPLANT;IMPLANTATION 209310 NDA Intersect ENT, Inc. 10599-003 10599-003-01 1 POUCH in 1 CARTON (10599-003-01) > 1 IMPLANT in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrength1.35MG
Approval Date:Dec 8, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 8, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Nov 29, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
Patent:➤ Try a Free TrialPatent Expiration:Mar 12, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT

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