FDA Approved Drugs Database

BeiGene

+2

  • Drug Name:

    TEVIMBRA

  • Application Number:

    761417

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE;INTRAVENOUS

  • Strength:

    100MG/10ML(10MG/ML)

  • Product Type:

  • Active Ingredient:

    TISLELIZUMAB-JSGR

  • Approval Date:

  • Legal Name:

    -

Carmel Biosciences

  • Drug Name:

    PREXXARTAN

  • Application Number:

    209139

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;ORAL

  • Strength:

    4MG/ML

  • Product Type:

    RX

  • Active Ingredient:

    VALSARTAN

  • Approval Date:

    2017-12-19

  • Legal Name:

    -

Civica Rx

+1

  • Drug Name:

    EPHEDRINE SULFATE

  • Application Number:

    215593

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;INTRAVENOUS

  • Strength:

    50MG/ML (50MG/ML)

  • Product Type:

    DISCN

  • Active Ingredient:

    EPHEDRINE SULFATE

  • Approval Date:

    2025-12-23

  • Legal Name:

    -

Innate Pharma

  • Drug Name:

    LUMOXITI

  • Application Number:

    761104

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE;INJECTION

  • Strength:

    1MG/VIAL

  • Product Type:

  • Active Ingredient:

    MOXETUMOMAB PASUDOTOX-TDFK

  • Approval Date:

  • Legal Name:

    -

Loxo Oncology Inc

+1

  • Drug Name:

    JAYPIRCA

  • Application Number:

    216059

  • Product Number:

    2

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    100MG

  • Product Type:

    RX

  • Active Ingredient:

    PIRTOBRUTINIB

  • Approval Date:

    2023-01-27

  • Legal Name:

    -

Medicines360

  • Drug Name:

    LILETTA

  • Application Number:

    206229

  • Product Number:

    1

  • Dosage Form:

    SYSTEM;INTRAUTERINE

  • Strength:

    52MG

  • Product Type:

    RX

  • Active Ingredient:

    LEVONORGESTREL

  • Approval Date:

    2015-02-26

  • Legal Name:

    -

Sarepta Therapeutics

+3

  • Drug Name:

    AMONDYS 45

  • Application Number:

    213026

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;INTRAVENOUS

  • Strength:

    100MG/2ML (50MG/ML)

  • Product Type:

    RX

  • Active Ingredient:

    CASIMERSEN

  • Approval Date:

    2021-02-25

  • Legal Name:

    -

SIGA Technologies

+1

  • Drug Name:

    TPOXX

  • Application Number:

    214518

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;INTRAVENOUS

  • Strength:

    200MG/20ML (10MG/ML)

  • Product Type:

    RX

  • Active Ingredient:

    TECOVIRIMAT

  • Approval Date:

    2022-05-18

  • Legal Name:

    -

SpringWorks Therapeutics

+7

  • Drug Name:

    GOMEKLI

  • Application Number:

    219389

  • Product Number:

    2

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    2MG

  • Product Type:

    RX

  • Active Ingredient:

    MIRDAMETINIB

  • Approval Date:

    2025-02-11

  • Legal Name:

    -

X4 Pharmaceuticals

  • Drug Name:

    XOLREMDI

  • Application Number:

    218709

  • Product Number:

    1

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    100MG

  • Product Type:

    RX

  • Active Ingredient:

    MAVORIXAFOR

  • Approval Date:

    2024-04-26

  • Legal Name:

    -

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