FDA Approved Drugs Database

Bionpharma

+125

  • Drug Name:

    LOPERAMIDE HYDROCHLORIDE

  • Application Number:

    220100

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;ORAL

  • Strength:

    1MG/7.5ML

  • Product Type:

    OTC

  • Active Ingredient:

    LOPERAMIDE HYDROCHLORIDE

  • Approval Date:

    2025-09-19

  • Legal Name:

    -

Akebia Therapeutics

+2

  • Drug Name:

    VAFSEO

  • Application Number:

    215192

  • Product Number:

    3

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    450MG

  • Product Type:

    RX

  • Active Ingredient:

    VADADUSTAT

  • Approval Date:

    2024-03-27

  • Legal Name:

    -

Aquestive Therapeutics

+2

  • Drug Name:

    EXSERVAN

  • Application Number:

    212640

  • Product Number:

    1

  • Dosage Form:

    FILM;ORAL

  • Strength:

    50MG

  • Product Type:

    DISCN

  • Active Ingredient:

    RILUZOLE

  • Approval Date:

    2019-11-22

  • Legal Name:

    -

Aucta Pharmaceuticals

+11

  • Drug Name:

    PYQUVI

  • Application Number:

    219417

  • Product Number:

    1

  • Dosage Form:

    SUSPENSION;ORAL

  • Strength:

    22.75MG/ML

  • Product Type:

    RX

  • Active Ingredient:

    DEFLAZACORT

  • Approval Date:

    2025-06-30

  • Legal Name:

    -

Blueprint Medicines

+5

  • Drug Name:

    GAVRETO

  • Application Number:

    214701

  • Product Number:

    1

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    100MG

  • Product Type:

  • Active Ingredient:

    PRALSETINIB

  • Approval Date:

  • Legal Name:

    -

Chimerix

  • Drug Name:

    MODEYSO

  • Application Number:

    219876

  • Product Number:

    1

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    EQ 125MG BASE

  • Product Type:

    RX

  • Active Ingredient:

    DORDAVIPRONE HYDROCHLORIDE

  • Approval Date:

    2025-08-06

  • Legal Name:

    -

Indivior

+13

  • Drug Name:

    OPVEE

  • Application Number:

    217470

  • Product Number:

    1

  • Dosage Form:

    SPRAY;NASAL

  • Strength:

    EQ 2.7MG BASE/SPRAY

  • Product Type:

    RX

  • Active Ingredient:

    NALMEFENE HYDROCHLORIDE

  • Approval Date:

    2023-05-22

  • Legal Name:

    -

Kramer Laboratories Inc

  • Drug Name:

    NIZORAL ANTI-DANDRUFF

  • Application Number:

    20310

  • Product Number:

    1

  • Dosage Form:

    SHAMPOO;TOPICAL

  • Strength:

    1%

  • Product Type:

    OTC

  • Active Ingredient:

    KETOCONAZOLE

  • Approval Date:

    1997-10-10

  • Legal Name:

    -

Piramal Pharma Solutions

+19

  • Drug Name:

    VARENICLINE TARTRATE

  • Application Number:

    217115

  • Product Number:

    2

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    EQ 1MG BASE

  • Product Type:

    RX

  • Active Ingredient:

    VARENICLINE TARTRATE

  • Approval Date:

    2024-07-23

  • Legal Name:

    -

Zealand Pharma

+1

  • Drug Name:

    ZEGALOGUE (AUTOINJECTOR)

  • Application Number:

    214231

  • Product Number:

    2

  • Dosage Form:

    SOLUTION;SUBCUTANEOUS

  • Strength:

    EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)

  • Product Type:

    DISCN

  • Active Ingredient:

    DASIGLUCAGON HYDROCHLORIDE

  • Approval Date:

    2021-03-22

  • Legal Name:

    -

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