NDC 71981-020

OXERVATE

Cenegermin-bkbj

OXERVATE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Domp. The primary component is Cenegermin.

Product ID71981-020_208e1798-eded-4339-8b33-78cc5cea9c2d
NDC71981-020
Product TypeHuman Prescription Drug
Proprietary NameOXERVATE
Generic NameCenegermin-bkbj
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2018-11-26
Marketing CategoryBLA / BLA
Application NumberBLA761094
Labeler NameDomp
Substance NameCENEGERMIN
Active Ingredient Strength20 ug/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71981-020-07

7 VIAL, MULTI-DOSE in 1 CARTON (71981-020-07) > 1 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2018-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71981-020-01 [71981002001]

OXERVATE SOLUTION/ DROPS
Marketing CategoryBLA
Application NumberBLA761094
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-26
Marketing End Date2019-11-22

NDC 71981-020-07 [71981002007]

OXERVATE SOLUTION/ DROPS
Marketing CategoryBLA
Application NumberBLA761094
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-26

Drug Details

Active Ingredients

IngredientStrength
CENEGERMIN20 ug/mL

OpenFDA Data

SPL SET ID:89e4bfec-d710-40ed-8885-5d13ba46b1cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2104341
  • 2104336
  • NDC Crossover Matching brand name "OXERVATE" or generic name "Cenegermin-bkbj"

    NDCBrand NameGeneric Name
    71981-001OXERVATEcenegermin-bkbj
    71981-020OXERVATEcenegermin-bkbj

    Trademark Results [OXERVATE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OXERVATE
    OXERVATE
    79205837 5352715 Live/Registered
    DOMPE' FARMACEUTICI S.P.A.
    2016-12-27
    OXERVATE
    OXERVATE
    79205724 5357221 Live/Registered
    DOMPE' FARMACEUTICI S.P.A.
    2016-12-27
    OXERVATE
    OXERVATE
    79170436 4868952 Live/Registered
    Dompé farmaceutici S.p.A.
    2015-05-06

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