U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 019821

Expand all

SORIATANE (ACITRETIN)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACITRETIN
Proprietary Name: SORIATANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019821
Product Number: 001
Approval Date: Oct 28, 1996
Applicant Holder Full Name: STIEFEL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SORIATANE (ACITRETIN)
17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACITRETIN
Proprietary Name: SORIATANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019821
Product Number: 003
Approval Date: Aug 6, 2009
Applicant Holder Full Name: STIEFEL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SORIATANE (ACITRETIN)
22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACITRETIN
Proprietary Name: SORIATANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019821
Product Number: 004
Approval Date: Aug 6, 2009
Applicant Holder Full Name: STIEFEL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SORIATANE (ACITRETIN)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACITRETIN
Proprietary Name: SORIATANE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019821
Product Number: 002
Approval Date: Oct 28, 1996
Applicant Holder Full Name: STIEFEL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top