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    Alendronate Sodium

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    01 4APOTEX

    02 3AUROBINDO PHARMA

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    01

    IMPAX LABS INC

    U.S.A
    American Pharma Summit
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    IMPAX LABS INC

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    RLD : No

    TE Code :

    ALENDRONATE SODIUM

    Brand Name : ALENDRONATE SODIUM

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE

    Approval Date : 2008-02-06

    Application Number : 75710

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    IMPAX LABS INC

    U.S.A
    American Pharma Summit
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    IMPAX LABS INC

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    RLD : No

    TE Code :

    ALENDRONATE SODIUM

    Brand Name : ALENDRONATE SODIUM

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 10MG BASE

    Approval Date : 2008-02-06

    Application Number : 75710

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    MERCK

    U.S.A
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    MERCK

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    RLD : Yes

    TE Code :

    ALENDRONATE SODIUM

    Brand Name : FOSAMAX

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2003-09-17

    Application Number : 21575

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    04

    ORGANON

    U.S.A
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    ORGANON

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    RLD : Yes

    TE Code :

    ALENDRONATE SODIUM

    Brand Name : FOSAMAX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1995-09-29

    Application Number : 20560

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    05

    ORGANON

    U.S.A
    American Pharma Summit
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    ORGANON

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    RLD : Yes

    TE Code :

    ALENDRONATE SODIUM

    Brand Name : FOSAMAX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1995-09-29

    Application Number : 20560

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    06

    ORGANON

    U.S.A
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    ORGANON

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    RLD : Yes

    TE Code :

    ALENDRONATE SODIUM

    Brand Name : FOSAMAX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1997-04-25

    Application Number : 20560

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    07

    ORGANON

    U.S.A
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    ORGANON

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    RLD : Yes

    TE Code :

    ALENDRONATE SODIUM

    Brand Name : FOSAMAX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2000-10-20

    Application Number : 20560

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    08

    ORGANON

    U.S.A
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    ORGANON

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    RLD : Yes

    TE Code : AB

    ALENDRONATE SODIUM

    Brand Name : FOSAMAX

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 70MG BASE

    Approval Date : 2000-10-20

    Application Number : 20560

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    09

    ORGANON LLC

    U.S.A
    American Pharma Summit
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    ORGANON LLC

    U.S.A
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    RLD : Yes

    TE Code :

    ALENDRONATE SODIUM; CHOLECALCIFEROL

    Brand Name : FOSAMAX PLUS D

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 70MG BASE;2,800 IU

    Approval Date : 2005-04-07

    Application Number : 21762

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    10

    ORGANON LLC

    U.S.A
    American Pharma Summit
    Not Confirmed
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    ORGANON LLC

    U.S.A
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    American Pharma Summit
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    RLD : Yes

    TE Code :

    ALENDRONATE SODIUM; CHOLECALCIFEROL

    Brand Name : FOSAMAX PLUS D

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 70MG BASE;5,600 IU

    Approval Date : 2007-04-26

    Application Number : 21762

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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