Product Details for ANDA 080745
ARISTOCORT (TRIAMCINOLONE ACETONIDE)
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRIAMCINOLONE ACETONIDE
Proprietary Name: ARISTOCORT
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080745
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ARISTOCORT A (TRIAMCINOLONE ACETONIDE)
Proprietary Name: ARISTOCORT
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080745
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRIAMCINOLONE ACETONIDE
Proprietary Name: ARISTOCORT A
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080745
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ARISTOCORT A
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080745
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status: Discontinued
Patent and Exclusivity Information