NDC 43538-900

Synalar

Fluocinolone Acetonide

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

Product ID43538-900_f11341ca-d1fb-499d-82b7-923d1ab1dab8
NDC43538-900
Product TypeHuman Prescription Drug
Proprietary NameSynalar
Generic NameFluocinolone Acetonide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2012-09-27
Marketing CategoryNDA / NDA
Application NumberNDA012787
Labeler NameMedimetriks Pharmaceuticals, Inc.
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43538-900-12

1 TUBE in 1 CARTON (43538-900-12) > 120 g in 1 TUBE
Marketing Start Date2012-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43538-900-99 [43538090099]

Synalar CREAM
Marketing CategoryNDA
Application NumberNDA012787
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-27

NDC 43538-900-12 [43538090012]

Synalar CREAM
Marketing CategoryNDA
Application NumberNDA012787
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2012-09-27

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.25 mg/g

OpenFDA Data

SPL SET ID:5af2e4c1-082b-48a0-aae7-72d4a68cbb2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191319
  • 1191315

    • Pharmacological Class

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