FDA Approved Drugs Database

SB PHARMCO

+9

  • Drug Name:

    AVANDARYL

  • Application Number:

    21700

  • Product Number:

    5

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

  • Product Type:

    DISCN

  • Active Ingredient:

    GLIMEPIRIDE; ROSIGLITAZONE MALEATE

  • Approval Date:

    2007-03-30

  • Legal Name:

    -

SCIOS LLC

  • Drug Name:

    NATRECOR

  • Application Number:

    20920

  • Product Number:

    1

  • Dosage Form:

    FOR SOLUTION;INTRAVENOUS

  • Strength:

    1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

  • Product Type:

    DISCN

  • Active Ingredient:

    NESIRITIDE

  • Approval Date:

    2001-08-10

  • Legal Name:

    -

SHIRE HUMAN GENETIC THERAPIES INC

+1

  • Drug Name:

    VPRIV

  • Application Number:

    22575

  • Product Number:

    2

  • Dosage Form:

    POWDER;INTRAVENOUS

  • Strength:

    200 UNITS/VIAL

  • Product Type:

  • Active Ingredient:

    VELAGLUCERASE ALFA

  • Approval Date:

  • Legal Name:

    -

SIGMA TAU

  • Drug Name:

    ONCASPAR

  • Application Number:

    103411

  • Product Number:

    1

  • Dosage Form:

    VIAL

  • Strength:

    750IU/VIAL

  • Product Type:

  • Active Ingredient:

    PEGASPARGASE

  • Approval Date:

  • Legal Name:

    -

Somerset Pharmaceuticals Inc

+28

  • Drug Name:

    CALCIUM CHLORIDE 10%

  • Application Number:

    218133

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE;INJECTION

  • Strength:

    100MG/ML

  • Product Type:

    RX

  • Active Ingredient:

    CALCIUM CHLORIDE

  • Approval Date:

    2024-12-17

  • Legal Name:

    -

Sebela Pharmaceuticals

+5

  • Drug Name:

    ONMEL

  • Application Number:

    22484

  • Product Number:

    1

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    200MG

  • Product Type:

    DISCN

  • Active Ingredient:

    ITRACONAZOLE

  • Approval Date:

    2010-04-29

  • Legal Name:

    -

SEPTODONT INC

+18

  • Drug Name:

    FLAVALTA

  • Application Number:

    216564

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;INJECTION

  • Strength:

    EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)

  • Product Type:

    RX

  • Active Ingredient:

    EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

  • Approval Date:

    2026-03-19

  • Legal Name:

    -

Shionogi

+10

  • Drug Name:

    XOCOVA

  • Application Number:

    220442

  • Product Number:

    1

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    125MG

  • Product Type:

    RX

  • Active Ingredient:

    ENSITRELVIR

  • Approval Date:

    2026-05-29

  • Legal Name:

    -

SHIRE LLC

  • Drug Name:

    SALURON

  • Application Number:

    11949

  • Product Number:

    1

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    50MG

  • Product Type:

    DISCN

  • Active Ingredient:

    HYDROFLUMETHIAZIDE

  • Approval Date:

    1982-01-01

  • Legal Name:

    -

SHIRE PLC

+26

  • Drug Name:

    ELAPRASE

  • Application Number:

    125151

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE; IV (INFUSION)

  • Strength:

    6MG/3ML

  • Product Type:

  • Active Ingredient:

    IDURSULFASE

  • Approval Date:

  • Legal Name:

    -

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