FDA Approved Drugs Database

Acrotech Biopharma

+9

  • Drug Name:

    ADQUEY

  • Application Number:

    219474

  • Product Number:

    1

  • Dosage Form:

    OINTMENT;TOPICAL

  • Strength:

    1%

  • Product Type:

    RX

  • Active Ingredient:

    DIFAMILAST

  • Approval Date:

    2026-02-12

  • Legal Name:

    -

Alfasigma

+1

  • Drug Name:

    ZELNORM

  • Application Number:

    21200

  • Product Number:

    2

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    EQ 6MG BASE

  • Product Type:

    DISCN

  • Active Ingredient:

    TEGASEROD MALEATE

  • Approval Date:

    2002-07-24

  • Legal Name:

    -

Biopharm

+1

  • Drug Name:

    ETODOLAC

  • Application Number:

    74929

  • Product Number:

    1

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    300MG

  • Product Type:

    DISCN

  • Active Ingredient:

    ETODOLAC

  • Approval Date:

    1998-01-30

  • Legal Name:

    -

Cumberland Pharmaceuticals

  • Drug Name:

    OMECLAMOX-PAK

  • Application Number:

    50824

  • Product Number:

    1

  • Dosage Form:

    CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL

  • Strength:

    500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

  • Product Type:

    DISCN

  • Active Ingredient:

    AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

  • Approval Date:

    2011-02-08

  • Legal Name:

    -

Elorac

  • Drug Name:

    FLUOROPLEX

  • Application Number:

    16765

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;TOPICAL

  • Strength:

    1%

  • Product Type:

    DISCN

  • Active Ingredient:

    FLUOROURACIL

  • Approval Date:

    1982-01-01

  • Legal Name:

    -

Eyenovia

  • Drug Name:

    MYDCOMBI

  • Application Number:

    215352

  • Product Number:

    1

  • Dosage Form:

    SPRAY, METERED;OPHTHALMIC

  • Strength:

    2.5%;1%

  • Product Type:

    DISCN

  • Active Ingredient:

    PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

  • Approval Date:

    2023-05-05

  • Legal Name:

    -

IntraBio

  • Drug Name:

    AQNEURSA

  • Application Number:

    219132

  • Product Number:

    1

  • Dosage Form:

    FOR SUSPENSION;ORAL

  • Strength:

    1GM/PACKET

  • Product Type:

    RX

  • Active Ingredient:

    LEVACETYLLEUCINE

  • Approval Date:

    2024-09-24

  • Legal Name:

    -

Ocular Therapeutix

  • Drug Name:

    DEXTENZA

  • Application Number:

    208742

  • Product Number:

    1

  • Dosage Form:

    INSERT;OPHTHALMIC

  • Strength:

    0.4MG

  • Product Type:

    RX

  • Active Ingredient:

    DEXAMETHASONE

  • Approval Date:

    2018-11-30

  • Legal Name:

    -

Shanghai Henlius Biotech

+2

  • Drug Name:

    POHERDY

  • Application Number:

    761450

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE;INTRAVENOUS

  • Strength:

    420MG/14ML(30MG/ML)

  • Product Type:

  • Active Ingredient:

    PERTUZUMAB-DPZB

  • Approval Date:

  • Legal Name:

    -

Xiromed

+98

  • Drug Name:

    METHYLENE BLUE

  • Application Number:

    219363

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;INTRAVENOUS

  • Strength:

    50MG/10ML (5MG/ML)

  • Product Type:

    RX

  • Active Ingredient:

    METHYLENE BLUE

  • Approval Date:

    2025-07-30

  • Legal Name:

    -

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