APPLICATION
ANDA204633
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-22
LATEST ACTION
2018-04-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ACITRETINPrescription
ACITRETIN 22.5MG · CAPSULE · ORAL
ACITRETINPrescription
ACITRETIN 10MG · CAPSULE · ORAL
ACITRETINPrescription
ACITRETIN 25MG · CAPSULE · ORAL
ACITRETINPrescription
ACITRETIN 17.5MG · CAPSULE · ORAL
Approval history
2018-04-19Labeling · Supplement 4 · standardAP
2015-10-06Labeling · Supplement 1 · standardAP
2015-05-22UNKNOWN · OriginalAP
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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