FDA Approved Drugs Database

Hi-Tech Pharmacal Co Inc

  • Drug Name:

    GATIFLOXACIN

  • Application Number:

    203190

  • Product Number:

    1

  • Dosage Form:

    SOLUTION; OPHTHALMIC

  • Strength:

    0.3%

  • Product Type:

  • Active Ingredient:

    GATIFLOXACIN

  • Approval Date:

  • Legal Name:

    -

BrightGene Bio-Medical Technology Co.,Ltd

+2

  • Drug Name:

    FONDAPARINUX SODIUM

  • Application Number:

    218312

  • Product Number:

    1

  • Dosage Form:

    SOLUTION;SUBCUTANEOUS

  • Strength:

    2.5MG/0.5ML (2.5MG/0.5ML)

  • Product Type:

    DISCN

  • Active Ingredient:

    FONDAPARINUX SODIUM

  • Approval Date:

    2024-12-18

  • Legal Name:

    -

Helsinn Advanced Synthesis

+8

  • Drug Name:

    TRUSELTIQ

  • Application Number:

    214622

  • Product Number:

    2

  • Dosage Form:

    CAPSULE;ORAL

  • Strength:

    100MG

  • Product Type:

    DISCN

  • Active Ingredient:

    INFIGRATINIB PHOSPHATE

  • Approval Date:

    2021-05-28

  • Legal Name:

    -

Hetero Drugs

+26

  • Drug Name:

    CYCLOPHOSPHAMIDE

  • Application Number:

    219271

  • Product Number:

    3

  • Dosage Form:

    INJECTION;SOLUTION

  • Strength:

    2000MG/10ML

  • Product Type:

  • Active Ingredient:

    CYCLOPHOSPHAMIDE

  • Approval Date:

  • Legal Name:

    -

Hikma Pharmaceuticals

+1143

  • Drug Name:

    XTRENBO

  • Application Number:

    761439

  • Product Number:

    2

  • Dosage Form:

    SOLUTION;INJECTION

  • Strength:

    120MG/1.7ML(70MG/ML)

  • Product Type:

  • Active Ingredient:

    DENOSUMAB-QBDE

  • Approval Date:

  • Legal Name:

    -

Hisamitsu Pharmaceutical Co., Inc.

+4

  • Drug Name:

    SECUADO

  • Application Number:

    212268

  • Product Number:

    3

  • Dosage Form:

    SYSTEM;TRANSDERMAL

  • Strength:

    7.6MG/24HR

  • Product Type:

    RX

  • Active Ingredient:

    ASENAPINE

  • Approval Date:

    2019-10-11

  • Legal Name:

    -

Hospira, Inc.

+862

  • Drug Name:

    NYVEPRIA

  • Application Number:

    761111

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE;INJECTION

  • Strength:

    6MG/0.6ML

  • Product Type:

  • Active Ingredient:

    PEGFILGRASTIM-APGF

  • Approval Date:

  • Legal Name:

    -

Hybio Pharmaceutical

+3

  • Drug Name:

    GLATIRAMER ACETATE

  • Application Number:

    214022

  • Product Number:

    1

  • Dosage Form:

    INJECTABLE;SUBCUTANEOUS

  • Strength:

    40MG/ML

  • Product Type:

    RX

  • Active Ingredient:

    GLATIRAMER ACETATE

  • Approval Date:

    2026-02-11

  • Legal Name:

    -

Impax Laboratories

+282

  • Drug Name:

    GLYBURIDE

  • Application Number:

    206079

  • Product Number:

    3

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    5MG

  • Product Type:

    RX

  • Active Ingredient:

    GLYBURIDE

  • Approval Date:

    2015-09-30

  • Legal Name:

    -

Indoco Remedies Limited

  • Drug Name:

    ALOGLIPTIN

  • Application Number:

    210002

  • Product Number:

    1

  • Dosage Form:

    TABLET;ORAL

  • Strength:

    6.25MG

  • Product Type:

  • Active Ingredient:

    ALOGLIPTIN BENZOATE

  • Approval Date:

  • Legal Name:

    -

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