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Last Updated: April 21, 2024

Details for New Drug Application (NDA): 019821


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NDA 019821 describes SORIATANE, which is a drug marketed by Stiefel Labs Inc and is included in one NDA. Additional details are available on the SORIATANE profile page.

The generic ingredient in SORIATANE is acitretin. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acitretin profile page.
Summary for 019821
Tradename:SORIATANE
Applicant:Stiefel Labs Inc
Ingredient:acitretin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019821

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 28, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 28, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 6, 2009TE:RLD:Yes

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