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    Accutane

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    01 6ACTAVIS LABS FL

    02 4AMNEAL PHARMS NY

    03 6AUROBINDO PHARMA

    04 4DR REDDYS LABS LTD

    05 3HOFFMANN LA ROCHE

    06 3MYLAN PHARMS INC

    07 6SUN PHARM

    08 6SUN PHARM INDS INC

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    01

    HOFFMANN LA ROCHE

    Switzerland
    The Pharmacy Technology
    Not Confirmed
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    HOFFMANN LA ROCHE

    Switzerland
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    The Pharmacy Technology
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    RLD : Yes

    TE Code :

    ISOTRETINOIN

    Brand Name : ACCUTANE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1982-05-07

    Application Number : 18662

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    02

    HOFFMANN LA ROCHE

    Switzerland
    The Pharmacy Technology
    Not Confirmed
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    HOFFMANN LA ROCHE

    Switzerland
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    RLD : Yes

    TE Code :

    ISOTRETINOIN

    Brand Name : ACCUTANE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1982-05-07

    Application Number : 18662

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    03

    HOFFMANN LA ROCHE

    Switzerland
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    HOFFMANN LA ROCHE

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    RLD : Yes

    TE Code :

    ISOTRETINOIN

    Brand Name : ACCUTANE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1983-03-28

    Application Number : 18662

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    04

    SUN PHARM INDS INC

    India
    The Pharmacy Technology
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    RLD : Yes

    TE Code : AB2

    ISOTRETINOIN

    Brand Name : ABSORICA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Approval Date : 2012-05-25

    Application Number : 21951

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB2

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    05

    SUN PHARM INDS INC

    India
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    SUN PHARM INDS INC

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    RLD : Yes

    TE Code : AB2

    ISOTRETINOIN

    Brand Name : ABSORICA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 20MG

    Approval Date : 2012-05-25

    Application Number : 21951

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB2

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    06

    SUN PHARM INDS INC

    India
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    RLD : Yes

    TE Code : AB2

    ISOTRETINOIN

    Brand Name : ABSORICA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 30MG

    Approval Date : 2012-05-25

    Application Number : 21951

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB2

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    07

    SUN PHARM INDS INC

    India
    The Pharmacy Technology
    Not Confirmed
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    SUN PHARM INDS INC

    India
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    RLD : Yes

    TE Code : AB2

    ISOTRETINOIN

    Brand Name : ABSORICA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 40MG

    Approval Date : 2012-05-25

    Application Number : 21951

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB2

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    08

    SUN PHARM INDS INC

    India
    The Pharmacy Technology
    Not Confirmed
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    SUN PHARM INDS INC

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    RLD : Yes

    TE Code : AB2

    ISOTRETINOIN

    Brand Name : ABSORICA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 25MG

    Approval Date : 2014-08-15

    Application Number : 21951

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB2

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    09

    SUN PHARM INDS INC

    India
    The Pharmacy Technology
    Not Confirmed
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    SUN PHARM INDS INC

    India
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    The Pharmacy Technology
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    RLD : Yes

    TE Code : AB2

    ISOTRETINOIN

    Brand Name : ABSORICA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 35MG

    Approval Date : 2014-08-15

    Application Number : 21951

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB2

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    10

    MYLAN PHARMS INC

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    MYLAN PHARMS INC

    U.S.A
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    The Pharmacy Technology
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    RLD : No

    TE Code : AB1

    ISOTRETINOIN

    Brand Name : AMNESTEEM

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 10MG

    Approval Date : 2002-11-08

    Application Number : 75945

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB1

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