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 suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
The generic ingredient in SINUVA is mometasone furoate. There are thirty drug master file entries for this compound. Twenty 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209310
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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: | RX | Dosage: | IMPLANT;IMPLANTATION | Strength | 1.35MG | ||||
| Approval Date: | Dec 8, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Mar 13, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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