NDC 47335-507

CEQUA

Cyclosporine

CEQUA is a Ophthalmic; Topical Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Cyclosporine.

Product ID47335-507_11d6e74c-6667-4c6f-80fd-59dfa881f316
NDC47335-507
Product TypeHuman Prescription Drug
Proprietary NameCEQUA
Generic NameCyclosporine
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC; TOPICAL
Marketing Start Date2018-08-15
Marketing CategoryNDA / NDA
Application NumberNDA210913
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameCYCLOSPORINE
Active Ingredient Strength0 mg/mL
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47335-507-97

1 POUCH in 1 BOX (47335-507-97) > 10 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-08-15
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 47335-507-97 [47335050797]

CEQUA SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA210913
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE.0009 mg/mL

OpenFDA Data

SPL SET ID:48c3d8a3-4289-4b52-9189-58b48596095c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2055021
  • 2055026
  • Pharmacological Class

    • Calcineurin Inhibitor Immunosuppressant [EPC]
    • Calcineurin Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "CEQUA" or generic name "Cyclosporine"

    NDCBrand NameGeneric Name
    47335-506CEQUACEQUA
    47335-507CEQUACEQUA
    0074-3108GengrafCyclosporine
    0074-3109GengrafCyclosporine
    0074-7269GengrafCyclosporine
    0078-0246Neoralcyclosporine
    0078-0248Neoralcyclosporine
    0023-9163RESTASIScyclosporine
    0023-5301Restasis MultiDosecyclosporine
    0078-0109Sandimmunecyclosporine
    0078-0110Sandimmunecyclosporine
    0078-0240Sandimmunecyclosporine
    0078-0241Sandimmunecyclosporine

    Trademark Results [CEQUA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CEQUA
    CEQUA
    88015703 not registered Live/Pending
    Sun Pharma Global FZE
    2018-06-26
    CEQUA
    CEQUA
    87772379 not registered Live/Pending
    Sun Pharma Global FZE
    2018-01-26
    CEQUA
    CEQUA
    87718043 not registered Live/Pending
    Sun Pharma Global FZE
    2017-12-12

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