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

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01 BARR LABS INC (2)

02 IMPAX LABS INC (4)

03 MYLAN (4)

04 SIGMAPHARM LABS LLC (4)

05 STIEFEL LABS INC (4)

06 TEVA PHARMS USA (2)

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01 CAPSULE;ORAL (20)

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01 DISCN (6)

02 RX (14)

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01 ACITRETIN (16)

02 SORIATANE (4)

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01 No (16)

02 Yes (4)

URL Supplier Web Content
CAPSULE;ORAL
10MG
2013-04-04
91455
ACITRETIN
RX
No
AB
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CAPSULE;ORAL
25MG
2013-04-04
91455
ACITRETIN
RX
No
AB
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CAPSULE;ORAL
10MG
2015-12-23
202552
ACITRETIN
RX
No
AB
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CAPSULE;ORAL
17.5MG
2015-12-23
202552
ACITRETIN
RX
No
AB
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CAPSULE;ORAL
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1996-10-28
19821
SORIATANE
DISCN
Yes
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CAPSULE;ORAL
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1996-10-28
19821
SORIATANE
DISCN
Yes
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CAPSULE;ORAL
17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2009-08-06
19821
SORIATANE
DISCN
Yes
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CAPSULE;ORAL
22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2009-08-06
19821
SORIATANE
DISCN
Yes
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CAPSULE;ORAL
10MG
2015-09-10
202148
ACITRETIN
RX
No
AB
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CAPSULE;ORAL
25MG
2015-09-10
202148
ACITRETIN
RX
No
AB
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