APPLICATION
ANDA076503
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-20
LATEST ACTION
2012-04-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
SOTRETDiscontinued
ISOTRETINOIN 30MG · CAPSULE · ORAL
Approval history
2012-04-12REMS · Supplement 16AP
2010-10-22REMS · Supplement 7AP
2010-03-25Labeling · Supplement 6AP
2009-08-20Labeling · Supplement 5AP
2007-11-02Labeling · Supplement 4AP
2007-02-06Labeling · Supplement 2AP
2007-02-06Labeling · Supplement 3AP
2005-08-12Labeling · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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