NDC 10599-003

Sinuva

Mometasone Furoate

Sinuva is a Intrasinal Implant in the Human Prescription Drug category. It is labeled and distributed by Intersect Ent, Inc.. The primary component is Mometasone Furoate.

Product ID10599-003_2000a4b1-7604-4443-93bc-0a0605d8f280
NDC10599-003
Product TypeHuman Prescription Drug
Proprietary NameSinuva
Generic NameMometasone Furoate
Dosage FormImplant
Route of AdministrationINTRASINAL
Marketing Start Date2018-02-01
Marketing CategoryNDA / NDA
Application NumberNDA209310
Labeler NameIntersect ENT, Inc.
Substance NameMOMETASONE FUROATE
Active Ingredient Strength1350 ug/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10599-003-01

1 POUCH in 1 CARTON (10599-003-01) > 1 IMPLANT in 1 POUCH
Marketing Start Date2018-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10599-003-01 [10599000301]

Sinuva IMPLANT
Marketing CategoryNDA
Application NumberNDA209310
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-01

Drug Details

Active Ingredients

IngredientStrength
MOMETASONE FUROATE1350 ug/1

OpenFDA Data

SPL SET ID:e33c1b23-cdc6-4f64-94ba-24b0b42c09bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1995983
  • 1995988

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Sinuva" or generic name "Mometasone Furoate"

    NDCBrand NameGeneric Name
    10599-003SinuvaSinuva
    0085-1341ASMANEXMometasone Furoate
    0085-1461ASMANEXMometasone Furoate
    0085-2222ASMANEX HFAMOMETASONE FUROATE
    0085-4333ASMANEX HFAMOMETASONE FUROATE
    0085-4334ASMANEX HFAMOMETASONE FUROATE
    0085-0370ELOCONmometasone furoate
    0085-0854ELOCONMometasone Furoate
    0085-3149ELOCONMometasone Furoate
    0168-0270Mometasone Furoatemometasone furoate
    0168-0271Mometasone Furoatemometasone furoate
    0168-0272Mometasone Furoatemometasone furoate
    0713-0634Mometasone FuroateMometasone Furoate
    0113-1720Nasonexmometasone furoate

    Trademark Results [Sinuva]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SINUVA
    SINUVA
    88370241 5879694 Live/Registered
    Intersect ENT Inc.
    2019-04-03
    SINUVA
    SINUVA
    87067979 5459633 Live/Registered
    Intersect ENT Inc.
    2016-06-10
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