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    Isotretinoin

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    01 6ACTAVIS LABS FL

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    05 3HOFFMANN LA ROCHE

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    01

    HOFFMANN LA ROCHE

    Switzerland
    Compamed
    Not Confirmed
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    HOFFMANN LA ROCHE

    Switzerland
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    Compamed
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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    Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
    Compamed
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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    Dosage Strength : 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

    Switzerland
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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    Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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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 : 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
    Compamed
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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
    Compamed
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    SUN PHARM INDS INC

    India
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    Compamed
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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
    Compamed
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    SUN PHARM INDS INC

    India
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    Compamed
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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
    Compamed
    Not Confirmed
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    MYLAN PHARMS INC

    U.S.A
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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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