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    Approved Drug Products containing Alendronate Sodium Trihydrate listed in the FDA Orange Book. Original Data : FDA Website

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    Alendronate, Sodium, Trihydrate

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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    Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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    01 NOVITIUM PHARMA (1)

    02 SUN PHARM (4)

    03 APOTEX (4)

    04 AUROBINDO PHARMA (3)

    05 CHARTWELL RX (9)

    06 CIPLA (5)

    07 HANGZHOU BINJIANG (4)

    08 HIKMA (1)

    09 IMPAX LABS INC (5)

    10 JUBILANT CADISTA (4)

    11 MERCK (1)

    12 MYLAN (2)

    13 ORGANON (5)

    14 ORGANON LLC (2)

    15 RADIUS (1)

    16 RISING (4)

    17 TEVA PHARMS (2)

    18 WATSON LABS (3)

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    01 SOLUTION;ORAL (3)

    02 TABLET, EFFERVESCENT;ORAL (1)

    03 TABLET;ORAL (56)

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    01 DISCN (31)

    02 RX (29)

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    01 ALENDRONATE SODIUM (51)

    02 BINOSTO (1)

    03 FOSAMAX (6)

    04 FOSAMAX PLUS D (2)

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    01 No (51)

    02 Yes (9)

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    NOVITIUM PHARMA

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      ALENDRONATE SODIUM

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      SOLUTION;ORAL
      EQ 70MG BASE/75ML
      2023-05-11
      214512
      ALENDRONATE SODIUM
      RX
      No
      AA
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      SUN PHARM

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      ALENDRONATE SODIUM

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      TABLET;ORAL
      EQ 5MG BASE
      2008-09-10
      90022
      ALENDRONATE SODIUM
      RX
      No
      AB
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      SUN PHARM

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      ALENDRONATE SODIUM

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      TABLET;ORAL
      EQ 10MG BASE
      2008-09-10
      90022
      ALENDRONATE SODIUM
      RX
      No
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      SUN PHARM

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      ALENDRONATE SODIUM

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      TABLET;ORAL
      EQ 35MG BASE
      2008-09-10
      90022
      ALENDRONATE SODIUM
      RX
      No
      AB
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      SUN PHARM

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      ALENDRONATE SODIUM

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      TABLET;ORAL
      EQ 70MG BASE
      2008-09-10
      90022
      ALENDRONATE SODIUM
      RX
      No
      AB
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      ORGANON

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        ALENDRONATE SODIUM

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        TABLET;ORAL
        EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        1995-09-29
        20560
        FOSAMAX
        DISCN
        Yes
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        ORGANON

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          ALENDRONATE SODIUM

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          TABLET;ORAL
          EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
          1995-09-29
          20560
          FOSAMAX
          DISCN
          Yes
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          ORGANON

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            ALENDRONATE SODIUM

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            TABLET;ORAL
            EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
            1997-04-25
            20560
            FOSAMAX
            DISCN
            Yes
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            ORGANON

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              ALENDRONATE SODIUM

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              TABLET;ORAL
              EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
              2000-10-20
              20560
              FOSAMAX
              DISCN
              Yes
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              ORGANON

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                ALENDRONATE SODIUM

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                TABLET;ORAL
                EQ 70MG BASE
                2000-10-20
                20560
                FOSAMAX
                RX
                Yes
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