FDA Approved Drugs Database

Assertio Therapeutics

+1

  • Drug Name:

    INDOCIN

  • Application Number:

    16059

  • Product Number:

    2

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

  • Product Type:

    DISCN

  • Active Ingredient:

    INDOMETHACIN

  • Approval Date:

    1982-01-01

  • Legal Name:

    -

BridgeBio Pharma

  • Drug Name:

    ATTRUBY

  • Application Number:

    216540

  • Product Number:

    1

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    EQ 356MG BASE

  • Product Type:

    RX

  • Active Ingredient:

    ACORAMIDIS HYDROCHLORIDE

  • Approval Date:

    2024-11-22

  • Legal Name:

    -

Calliditas Therapeutics AB

  • Drug Name:

    TARPEYO

  • Application Number:

    215935

  • Product Number:

    1

  • Dosage Form:

    CAPSULE, DELAYED RELEASE;ORAL

  • Strength:

    4MG

  • Product Type:

    RX

  • Active Ingredient:

    BUDESONIDE

  • Approval Date:

    2021-12-15

  • Legal Name:

    -

CorMedix

+1

  • Drug Name:

    DEFENCATH

  • Application Number:

    214520

  • Product Number:

    2

  • Dosage Form:

    SOLUTION;N/A

  • Strength:

    5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)

  • Product Type:

    RX

  • Active Ingredient:

    HEPARIN SODIUM; TAUROLIDINE

  • Approval Date:

    2023-11-15

  • Legal Name:

    -

Delcath Systems

  • Drug Name:

    HEPZATO

  • Application Number:

    201848

  • Product Number:

    1

  • Dosage Form:

    POWDER;INTRA-ARTERIAL

  • Strength:

    EQ 50MG BASE/VIAL

  • Product Type:

    RX

  • Active Ingredient:

    MELPHALAN HYDROCHLORIDE

  • Approval Date:

    2023-08-14

  • Legal Name:

    -

Geron

+1

  • Drug Name:

    RYTELO

  • Application Number:

    217779

  • Product Number:

    2

  • Dosage Form:

    POWDER;INTRAVENOUS

  • Strength:

    EQ 188MG BASE/VIAL

  • Product Type:

    RX

  • Active Ingredient:

    IMETELSTAT SODIUM

  • Approval Date:

    2024-06-06

  • Legal Name:

    -

Norgine

  • Drug Name:

    PLENVU

  • Application Number:

    209381

  • Product Number:

    1

  • Dosage Form:

    FOR SOLUTION;ORAL

  • Strength:

    7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM

  • Product Type:

    RX

  • Active Ingredient:

    ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

  • Approval Date:

    2018-05-04

  • Legal Name:

    -

Taiho Oncology

+4

  • Drug Name:

    LYTGOBI

  • Application Number:

    214801

  • Product Number:

    2

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    16MG

  • Product Type:

    DISCN

  • Active Ingredient:

    FUTIBATINIB

  • Approval Date:

    2025-07-28

  • Legal Name:

    -

Tarsus Pharmaceuticals

  • Drug Name:

    XDEMVY

  • Application Number:

    217603

  • Product Number:

    1

  • Dosage Form:

    SOLUTION/DROPS;OPHTHALMIC

  • Strength:

    0.25%

  • Product Type:

    RX

  • Active Ingredient:

    LOTILANER

  • Approval Date:

    2023-07-24

  • Legal Name:

    -

Trevena

+2

  • Drug Name:

    OLINVYK

  • Application Number:

    210730

  • Product Number:

    3

  • Dosage Form:

    SOLUTION;INTRAVENOUS

  • Strength:

    30MG/30ML (1MG/ML)

  • Product Type:

    DISCN

  • Active Ingredient:

    OLICERIDINE

  • Approval Date:

    2020-10-30

  • Legal Name:

    -

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