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    Approved Drug Products containing 00627_FLUKA listed in the FDA Orange Book. Original Data : FDA Website

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    00627_FLUKA

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 STRIDES PHARMA (1)

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    05 B BRAUN MEDICAL INC (4)

    06 BAXTER HLTHCARE (2)

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    17 MILLA PHARMS (3)

    18 MYLAN LABS LTD (3)

    19 NOVEL LABS INC (1)

    20 PADDOCK LLC (1)

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    01 EMULSION;INTRAVENOUS (7)

    02 INJECTABLE;INJECTION (37)

    03 INJECTABLE;INTRATHECAL (1)

    04 POWDER;ORAL (1)

    05 SOLUTION;INTRAMUSCULAR, INTRAVENOUS (7)

    06 SOLUTION;IRRIGATION (2)

    07 SOLUTION;ORAL (9)

    08 TABLET;ORAL (1)

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    01 DISCN (2)

    02 RX (59)

    03 Blank (4)

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    01 COLPREP KIT (1)

    02 ELLIOTTS B SOLUTION (1)

    03 KABIVEN IN PLASTIC CONTAINER (4)

    04 MAGNESIUM SULFATE (10)

    05 MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE (1)

    06 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER (7)

    07 MAGNESIUM SULFATE IN PLASTIC CONTAINER (27)

    08 MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE (1)

    09 PERIKABIVEN IN PLASTIC CONTAINER (3)

    10 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE (3)

    11 SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE (2)

    12 SUCLEAR (1)

    13 SUPREP BOWEL PREP KIT (1)

    14 SUTAB (1)

    15 TIS-U-SOL (1)

    16 TIS-U-SOL IN PLASTIC CONTAINER (1)

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    01 No (38)

    02 Yes (23)

    03 Blank (4)

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    STRIDES PHARMA

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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
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    MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

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    SOLUTION;ORAL
    1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
    2023-11-22
    215469
    SODIUM SULFATE, POTASS...
    RX
    No
    AA
    Strides Pharma Science

    CPhI Worldwide, Milan

    Booth #5C33

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    BAXTER HLTHCARE

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    MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE

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    SOLUTION;IRRIGATION
    20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML
    1982-01-01
    18336
    TIS-U-SOL IN PLASTIC C...
    RX
    No
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    BAXTER HLTHCARE

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    MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE

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    SOLUTION;IRRIGATION
    20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML
    1982-02-19
    18508
    TIS-U-SOL
    RX
    No
    AT
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    FRESENIUS KABI USA

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      Flag Austria
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      MAGNESIUM SULFATE

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      SOLUTION;INTRAMUSCULAR, INTRAVENOUS
      5GM/10ML (500MG/ML)
      1986-09-08
      19316
      MAGNESIUM SULFATE
      RX
      Yes
      AP
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      FRESENIUS KABI USA

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        MAGNESIUM SULFATE

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        SOLUTION;INTRAMUSCULAR, INTRAVENOUS
        1GM/2ML (500MG/ML)
        1986-09-08
        19316
        MAGNESIUM SULFATE
        RX
        Yes
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        FRESENIUS KABI USA

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          MAGNESIUM SULFATE

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          SOLUTION;INTRAMUSCULAR, INTRAVENOUS
          10GM/20ML (500MG/ML)
          2016-01-29
          19316
          MAGNESIUM SULFATE
          RX
          Yes
          AP
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          FRESENIUS KABI USA

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            MAGNESIUM SULFATE

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            SOLUTION;INTRAMUSCULAR, INTRAVENOUS
            25GM/50ML (500MG/ML)
            2016-01-29
            19316
            MAGNESIUM SULFATE
            RX
            Yes
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            HOSPIRA

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            MAGNESIUM SULFATE

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            INJECTABLE;INJECTION
            4GM/100ML (40MG/ML)
            1994-06-24
            20309
            MAGNESIUM SULFATE IN P...
            RX
            Yes
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            HOSPIRA

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            MAGNESIUM SULFATE

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            INJECTABLE;INJECTION
            4GM/50ML (80MG/ML)
            1994-06-24
            20309
            MAGNESIUM SULFATE IN P...
            RX
            Yes
            AP
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            HOSPIRA

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            MAGNESIUM SULFATE

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            INJECTABLE;INJECTION
            2GM/50ML (40MG/ML)
            2007-01-26
            20309
            MAGNESIUM SULFATE IN P...
            RX
            Yes
            AP
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