NDC 62935-453

ELIGARD

Leuprolide Acetate

ELIGARD is a Subcutaneous Kit in the Human Prescription Drug category. It is labeled and distributed by Tolmar Pharmaceuticals Inc.. The primary component is .

Product ID62935-453_0c555d76-f3ff-415a-b04c-d63ed000b216
NDC62935-453
Product TypeHuman Prescription Drug
Proprietary NameELIGARD
Generic NameLeuprolide Acetate
Dosage FormKit
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2005-01-07
Marketing CategoryNDA / NDA
Application NumberNDA021731
Labeler NameTOLMAR PHARMACEUTICALS INC.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62935-453-45

1 KIT in 1 CARTON (62935-453-45) * .375 mL in 1 SYRINGE (62935-454-44) * .375 mL in 1 SYRINGE (62935-455-45)
Marketing Start Date2005-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62935-453-45 [62935045345]

ELIGARD KIT
Marketing CategoryNDA
Application NumberNDA021731
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-01-07

Drug Details

OpenFDA Data

SPL SET ID:b78d1919-9dee-44fa-90f9-e0a26d32481d
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 825333
  • 825335
  • 825334
  • 825325
  • 752884
  • 752899
  • 752889
  • 752894
  • NDC Crossover Matching brand name "ELIGARD" or generic name "Leuprolide Acetate"

    NDCBrand NameGeneric Name
    62935-223ELIGARDELIGARD
    62935-453ELIGARDELIGARD
    62935-753ELIGARDELIGARD
    62935-222ELIGARDELIGARD
    62935-303ELIGARDELIGARD
    62935-752ELIGARDELIGARD
    62935-452ELIGARDELIGARD
    62935-302ELIGARDELIGARD
    0074-3346Lupron Depotleuprolide acetate
    0074-3473Lupron Depotleuprolide acetate
    0074-3641Lupron Depotleuprolide acetate
    0074-3642Lupron Depotleuprolide acetate
    0074-3663Lupron Depotleuprolide acetate
    0074-3683Lupron Depotleuprolide acetate
    0074-2108Lupron Depot-PEDleuprolide acetate
    0074-2282Lupron Depot-PEDleuprolide acetate
    0074-2440Lupron Depot-PEDleuprolide acetate

    Trademark Results [ELIGARD]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ELIGARD
    ELIGARD
    90593589 not registered Live/Pending
    Tolmar Therapeutics, Inc.
    2021-03-22
    ELIGARD
    ELIGARD
    76331615 2645629 Live/Registered
    TOLMAR THERAPEUTICS, INC.
    2001-10-30
    ELIGARD
    ELIGARD
    75128282 2115522 Dead/Cancelled
    Synthelabo
    1996-07-01

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