NDC 89141-123

Soltamox

Tamoxifen Citrate

Soltamox is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Fortovia Therapeutics Inc.. The primary component is Tamoxifen Citrate.

Product ID89141-123_0e8ed8c2-2f89-4585-88b3-de75c37be094
NDC89141-123
Product TypeHuman Prescription Drug
Proprietary NameSoltamox
Generic NameTamoxifen Citrate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2005-10-29
Marketing End Date2022-06-30
Marketing CategoryNDA / NDA
Application NumberNDA021807
Labeler NameFortovia Therapeutics Inc.
Substance NameTAMOXIFEN CITRATE
Active Ingredient Strength20 mg/10mL
Pharm ClassesEstrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC Exclude FlagN

Packaging

NDC 89141-123-01

1 CONTAINER in 1 CARTON (89141-123-01) > 150 mL in 1 CONTAINER
Marketing Start Date2018-02-28
Marketing End Date2022-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 89141-123-01 [89141012301]

Soltamox LIQUID
Marketing CategoryNDA
Application NumberNDA021807
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-28

Drug Details

Active Ingredients

IngredientStrength
TAMOXIFEN CITRATE20 mg/10mL

OpenFDA Data

SPL SET ID:bd72fd53-ae0c-4080-9b7f-2d294b14cc86
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 389230
  • 644304

    • Pharmacological Class

    • Estrogen Agonist/Antagonist [EPC]
    • Selective Estrogen Receptor Modulators [MoA]

    NDC Crossover Matching brand name "Soltamox" or generic name "Tamoxifen Citrate"

    NDCBrand NameGeneric Name
    51862-682SOLTAMOXTAMOXIFEN CITRATE
    89141-123SoltamoxSoltamox
    0179-0224Tamoxifen CitrateTamoxifen Citrate
    0378-0144Tamoxifen CitrateTamoxifen Citrate
    0378-0274Tamoxifen CitrateTamoxifen Citrate
    0591-2472Tamoxifen CitrateTamoxifen Citrate
    0591-2473Tamoxifen CitrateTamoxifen Citrate
    50090-0485Tamoxifen CitrateTamoxifen Citrate
    50090-0942Tamoxifen CitrateTamoxifen Citrate
    51407-439Tamoxifen CitrateTamoxifen Citrate
    51407-440Tamoxifen CitrateTamoxifen Citrate
    51862-446Tamoxifen CitrateTamoxifen Citrate
    51862-447Tamoxifen CitrateTamoxifen Citrate
    51862-449Tamoxifen CitrateTamoxifen Citrate
    51862-450Tamoxifen CitrateTamoxifen Citrate
    51862-642Tamoxifen CitrateTamoxifen Citrate
    51862-643Tamoxifen CitrateTamoxifen Citrate
    59651-299Tamoxifen CitrateTamoxifen Citrate
    59651-300Tamoxifen CitrateTamoxifen Citrate
    60429-909Tamoxifen CitrateTamoxifen Citrate
    60429-910Tamoxifen CitrateTamoxifen Citrate

    Trademark Results [Soltamox]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOLTAMOX
    SOLTAMOX
    78401536 3245337 Live/Registered
    ROSEMONT PHARMACEUTICALS LTD
    2004-04-14
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.