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    Approved Drug Products containing 78034 listed in the FDA Orange Book. Original Data : FDA Website

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    01 BIOCON PHARMA (5)

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    01 TABLET;ORAL (5)

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    01 RX (5)

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    01 SIMVASTATIN (5)

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    01 No (5)

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    SIMVASTATIN

    PDF Supplier PDF
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    TABLET; ORAL
    20MG
    2006-12-20
    78034
    SIMVASTATIN
    RX
    No
    AB
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    SIMVASTATIN

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    5MG
    2006-12-20
    78034
    SIMVASTATIN
    RX
    No
    AB
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    SIMVASTATIN

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    40MG
    2006-12-20
    78034
    SIMVASTATIN
    RX
    No
    AB
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    SIMVASTATIN

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    10MG
    2006-12-20
    78034
    SIMVASTATIN
    RX
    No
    AB
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    SIMVASTATIN

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    80MG
    2006-12-20
    78034
    SIMVASTATIN
    RX
    No
    AB
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    Looking for FDA Orange Book APPLICATION 78034

    Looking for FDA Orange Book APPLICATION 78034 5

    19

    Biocon, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is SIMVASTATIN, with a corresponding application number 78034.

    Regulatory Information RX

    With a dosage strength 20MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug No

    Approved since 2006-12-20

    Therapeutic Equivalence (TE) Code AB

    18

    Biocon, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is SIMVASTATIN, with a corresponding application number 78034.

    Regulatory Information RX

    With a dosage strength 5MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug No

    Approved since 2006-12-20

    Therapeutic Equivalence (TE) Code AB

    17

    Biocon, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is SIMVASTATIN, with a corresponding application number 78034.

    Regulatory Information RX

    With a dosage strength 40MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug No

    Approved since 2006-12-20

    Therapeutic Equivalence (TE) Code AB

    16

    Biocon, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is SIMVASTATIN, with a corresponding application number 78034.

    Regulatory Information RX

    With a dosage strength 10MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug No

    Approved since 2006-12-20

    Therapeutic Equivalence (TE) Code AB

    15

    Biocon, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is SIMVASTATIN, with a corresponding application number 78034.

    Regulatory Information RX

    With a dosage strength 80MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug No

    Approved since 2006-12-20

    Therapeutic Equivalence (TE) Code AB

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