NDC 0088-2160

Arava

Leflunomide

Arava is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Leflunomide.

Product ID0088-2160_04c7b15c-5ad7-4f56-a94f-70fde67d843f
NDC0088-2160
Product TypeHuman Prescription Drug
Proprietary NameArava
Generic NameLeflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-09-10
Marketing CategoryNDA / NDA
Application NumberNDA020905
Labeler Namesanofi-aventis U.S. LLC
Substance NameLEFLUNOMIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0088-2160-30

1 BOTTLE in 1 CARTON (0088-2160-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date1998-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0088-2160-30 [00088216030]

Arava TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020905
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-09-19

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE10 mg/1

OpenFDA Data

SPL SET ID:320f63f2-fac3-4aee-aff8-85724e00ef52
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213379
  • 213380
  • 213377
  • 205285
  • 205284
  • 205286
  • Pharmacological Class

    • Antirheumatic Agent [EPC]

    NDC Crossover Matching brand name "Arava" or generic name "Leflunomide"

    NDCBrand NameGeneric Name
    0088-2160Aravaleflunomide
    0088-2161Aravaleflunomide
    0088-2162Aravaleflunomide
    0955-1735Leflunomideleflunomide
    0955-1737Leflunomideleflunomide
    10702-277LeflunomideLeflunomide
    10702-278LeflunomideLeflunomide
    13811-677LeflunomideLeflunomide
    13811-678LeflunomideLeflunomide
    23155-043LeflunomideLeflunomide

    Trademark Results [Arava]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARAVA
    ARAVA
    97314298 not registered Live/Pending
    THE BOON HUB
    2022-03-16
    ARAVA
    ARAVA
    97075653 not registered Live/Pending
    CAPACITACION Y ASESORIAS NACIONALES E INTERNACIONALES DESARROLLO INTEGRAL CHILESPA
    2021-10-14
    ARAVA
    ARAVA
    87727567 not registered Live/Pending
    Israel Weapon Industries (I.W.I) Ltd.
    2017-12-20
    ARAVA
    ARAVA
    76328667 not registered Dead/Abandoned
    Makhteshim-Agan of North America Inc.
    2001-10-23
    ARAVA
    ARAVA
    75331547 2385952 Live/Registered
    SANOFI-AVENTIS DEUTSCHLAND GMBH
    1997-07-28
    ARAVA
    ARAVA
    75196723 2143705 Dead/Cancelled
    Arava Export Growers, Ltd.
    1996-11-12

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.