FDA Approved Drugs Database

Akeso

  • Drug Name:

    PENPULIMAB-KCQX

  • Application Number:

    761258

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE;INTRAVENOUS

  • Strength:

    100MG/10ML(10MG/ML)

  • Product Type:

  • Active Ingredient:

    PENPULIMAB-KCQX

  • Approval Date:

  • Legal Name:

    -

Amylyx Pharmaceuticals

  • Drug Name:

    RELYVRIO

  • Application Number:

    216660

  • Product Number:

    1

  • Dosage Form:

    FOR SUSPENSION;ORAL

  • Strength:

    3GM/PACKET; 1GM/PACKET

  • Product Type:

    DISCN

  • Active Ingredient:

    SODIUM PHENYLBUTYRATE; TAURURSODIOL

  • Approval Date:

    2022-09-29

  • Legal Name:

    -

Axsome Therapeutics

+1

  • Drug Name:

    SUNOSI

  • Application Number:

    211230

  • Product Number:

    2

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    EQ 150MG BASE

  • Product Type:

    RX

  • Active Ingredient:

    SOLRIAMFETOL HYDROCHLORIDE

  • Approval Date:

    2019-06-17

  • Legal Name:

    -

BioCryst Pharmaceuticals

+6

  • Drug Name:

    ORLADEYO

  • Application Number:

    219776

  • Product Number:

    4

  • Dosage Form:

    PELLETS;ORAL

  • Strength:

    EQ 132MG BASE/PACKET

  • Product Type:

    RX

  • Active Ingredient:

    BEROTRALSTAT DIHYDROCHLORIDE

  • Approval Date:

    2025-12-11

  • Legal Name:

    -

CSL Vifor

+3

  • Drug Name:

    VELTASSA

  • Application Number:

    205739

  • Product Number:

    4

  • Dosage Form:

    POWDER;ORAL

  • Strength:

    EQ 1GM BASE/PACKET

  • Product Type:

    RX

  • Active Ingredient:

    PATIROMER SORBITEX CALCIUM

  • Approval Date:

    2023-10-02

  • Legal Name:

    -

Cytokinetics

+3

  • Drug Name:

    MYQORZO

  • Application Number:

    219083

  • Product Number:

    4

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    20MG

  • Product Type:

    RX

  • Active Ingredient:

    AFICAMTEN

  • Approval Date:

    2025-12-19

  • Legal Name:

    -

Horizon Therapeutics

+1

  • Drug Name:

    PENNSAID

  • Application Number:

    204623

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;TOPICAL

  • Strength:

    2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

  • Product Type:

    DISCN

  • Active Ingredient:

    DICLOFENAC SODIUM

  • Approval Date:

    2014-01-16

  • Legal Name:

    -

Verrica Pharmaceuticals

  • Drug Name:

    YCANTH

  • Application Number:

    212905

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;TOPICAL

  • Strength:

    0.7%

  • Product Type:

    RX

  • Active Ingredient:

    CANTHARIDIN

  • Approval Date:

    2023-07-21

  • Legal Name:

    -

VKT Pharma

+14

  • Drug Name:

    SUMATRIPTAN SUCCINATE

  • Application Number:

    219036

  • Product Number:

    3

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    EQ 100MG BASE

  • Product Type:

    RX

  • Active Ingredient:

    SUMATRIPTAN SUCCINATE

  • Approval Date:

    2024-12-31

  • Legal Name:

    -

Xcovery

+1

  • Drug Name:

    ENSACOVE

  • Application Number:

    218171

  • Product Number:

    2

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    EQ 100MG BASE

  • Product Type:

    RX

  • Active Ingredient:

    ENSARTINIB HYDROCHLORIDE

  • Approval Date:

    2024-12-18

  • Legal Name:

    -

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