NDC 43538-920

Synalar

Fluocinolone Acetonide

Synalar is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Medimetriks Pharmaceuticals, Inc.. The primary component is Fluocinolone Acetonide.

Product ID43538-920_02f3e570-4fe4-40f1-a300-742857893a96
NDC43538-920
Product TypeHuman Prescription Drug
Proprietary NameSynalar
Generic NameFluocinolone Acetonide
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2012-05-31
Marketing CategoryNDA / NDA
Application NumberNDA015296
Labeler NameMedimetriks Pharmaceuticals, Inc.
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43538-920-60

1 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-60) > 60 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2012-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43538-920-60 [43538092060]

Synalar SOLUTION
Marketing CategoryNDA
Application NumberNDA015296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-05-31

NDC 43538-920-90 [43538092090]

Synalar SOLUTION
Marketing CategoryNDA
Application NumberNDA015296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-08-15

NDC 43538-920-99 [43538092099]

Synalar SOLUTION
Marketing CategoryNDA
Application NumberNDA015296
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-15

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.1 mg/mL

OpenFDA Data

SPL SET ID:b48f3e2f-f92d-41b1-8e99-08f0b72c4672
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191313
  • 1191310

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Synalar" or generic name "Fluocinolone Acetonide"

    NDCBrand NameGeneric Name
    43538-900Synalarfluocinolone acetonide
    43538-901SynalarFluocinolone acetonide
    43538-910Synalarfluocinolone acetonide
    43538-911SynalarFluocinolone acetonide
    43538-920Synalarfluocinolone acetonide
    0299-5500Capexfluocinolone acetonide
    39328-079Flac Otic Oilfluocinolone acetonide
    0168-0058Fluocinolone Acetonidefluocinolone acetonide
    0168-0059Fluocinolone Acetonidefluocinolone acetonide
    0168-0060Fluocinolone Acetonidefluocinolone acetonide
    0168-0064Fluocinolone Acetonidefluocinolone acetonide
    0713-0223Fluocinolone AcetonideFluocinolone Acetonide
    0713-0224Fluocinolone AcetonideFluocinolone Acetonide
    0713-0324Fluocinolone AcetonideFluocinolone Acetonide
    0713-0325Fluocinolone AcetonideFluocinolone Acetonide
    0713-0709FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDE
    10135-670fluocinolone acetonidefluocinolone acetonide
    13925-506Fluocinolone Acetonidefluocinolone acetonide
    13925-507Fluocinolone Acetonidefluocinolone acetonide
    42291-283Fluocinolone AcetonideFluocinolone Acetonide
    42291-284Fluocinolone AcetonideFluocinolone Acetonide
    42291-285Fluocinolone AcetonideFluocinolone Acetonide
    43386-069Fluocinolone AcetonideFluocinolone Acetonide
    13925-508Fluocinolone acetonide 0.01%fluocinolone acetonide
    24208-416RetisertFluocinolone Acetonide
    43538-921Synalar TSfluocinolone acetonide

    Trademark Results [Synalar]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYNALAR
    SYNALAR
    98572275 not registered Live/Pending
    Productos Farmaceuticos, S.A. de C.V.
    2024-05-28
    SYNALAR
    SYNALAR
    85740050 4564897 Live/Registered
    Medimetriks Pharmaceuticals, Inc.
    2012-09-27
    SYNALAR
    SYNALAR
    85455190 not registered Dead/Abandoned
    Medimetriks Pharmaceuticals, Inc.
    2011-10-25
    SYNALAR
    SYNALAR
    72089960 0714627 Dead/Cancelled
    SYNTEX S.A.
    1960-01-29
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.