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Generated: January 22, 2019

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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. It is available from two suppliers. 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. Seven 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
Pharmacology for NDA: 019821
Medical Subject Heading (MeSH) Categories for 019821
Suppliers and Packaging for NDA: 019821
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SORIATANE acitretin CAPSULE;ORAL 019821 NDA Stiefel Laboratories Inc 0145-0090 0145-0090-25 30 CAPSULE in 1 BOTTLE (0145-0090-25)
SORIATANE acitretin CAPSULE;ORAL 019821 NDA Stiefel Laboratories Inc 0145-0091 0145-0091-25 30 CAPSULE in 1 BOTTLE (0145-0091-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Oct 28, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Oct 28, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength17.5MG
Approval Date:Aug 6, 2009TE:ABRLD:Yes

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Mallinckrodt
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