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

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    duraspiron

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    01

    ACTAVIS ELIZABETH

    Ireland
    34th IFSCC
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    ACTAVIS ELIZABETH

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    RLD : No

    TE Code :

    SPIRONOLACTONE

    Brand Name : SPIRONOLACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date : 1999-07-29

    Application Number : 40353

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    ACTAVIS ELIZABETH

    Ireland
    34th IFSCC
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    RLD : No

    TE Code :

    SPIRONOLACTONE

    Brand Name : SPIRONOLACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 1999-07-29

    Application Number : 40353

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    ACTAVIS ELIZABETH

    Ireland
    34th IFSCC
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    RLD : No

    TE Code :

    SPIRONOLACTONE

    Brand Name : SPIRONOLACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Approval Date : 2006-03-15

    Application Number : 40353

    RX/OTC/DISCN : DISCN

    RLD : No

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    04

    PFIZER

    U.S.A
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    RLD : Yes

    TE Code : AB

    SPIRONOLACTONE

    Brand Name : ALDACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date : 1982-12-30

    Application Number : 12151

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    05

    PFIZER

    U.S.A
    34th IFSCC
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    RLD : Yes

    TE Code : AB

    SPIRONOLACTONE

    Brand Name : ALDACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Approval Date : 1983-12-30

    Application Number : 12151

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    PFIZER

    U.S.A
    34th IFSCC
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    RLD : Yes

    TE Code : AB

    SPIRONOLACTONE

    Brand Name : ALDACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 1983-12-30

    Application Number : 12151

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    07

    PFIZER

    U.S.A
    34th IFSCC
    Not Confirmed
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    PFIZER

    U.S.A
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    RLD : Yes

    TE Code : AB

    HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

    Brand Name : ALDACTAZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG;25MG

    Approval Date : 1982-12-30

    Application Number : 12616

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    08

    PFIZER

    U.S.A
    34th IFSCC
    Not Confirmed
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    PFIZER

    U.S.A
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    RLD : Yes

    TE Code :

    HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

    Brand Name : ALDACTAZIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG;50MG

    Approval Date : 1982-12-30

    Application Number : 12616

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    09

    MYLAN

    U.S.A
    34th IFSCC
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    MYLAN

    U.S.A
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    RLD : No

    TE Code : AB

    SPIRONOLACTONE

    Brand Name : SPIRONOLACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Approval Date : 2001-08-20

    Application Number : 40424

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    MYLAN

    U.S.A
    34th IFSCC
    Not Confirmed
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    MYLAN

    U.S.A
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    34th IFSCC
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    RLD : No

    TE Code : AB

    SPIRONOLACTONE

    Brand Name : SPIRONOLACTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date : 2001-08-20

    Application Number : 40424

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    blank

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