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 thirteen 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-three 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:	13

Pharmacology for NDA: 209310

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 209310

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

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:	RX	Dosage:	IMPLANT;IMPLANTATION			Strength	1.35MG
Approval Date:	Dec 8, 2017	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 24, 2034	Product Flag?	Y	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:	⤷ Sign Up	Patent Expiration:	Oct 3, 2031	Product 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:	⤷ Sign Up	Patent Expiration:	Mar 13, 2034	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209310

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	⤷ Sign Up	⤷ Sign Up
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	⤷ Sign Up	⤷ Sign Up
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	⤷ Sign Up	⤷ Sign Up
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	⤷ Sign Up	⤷ Sign Up
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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