Product Details for NDA 018116
CYCLOCORT (AMCINONIDE)
0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMCINONIDE
Proprietary Name: CYCLOCORT
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018116
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CYCLOCORT (AMCINONIDE)
Proprietary Name: CYCLOCORT
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018116
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMCINONIDE
Proprietary Name: CYCLOCORT
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018116
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
Proprietary Name: CYCLOCORT
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018116
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