Product Details for ANDA 080474
HYTONE (HYDROCORTISONE)
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCORTISONE
Proprietary Name: HYTONE
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080474
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DERMIK LABORATORIES DIV AVENTIS PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HYTONE (HYDROCORTISONE)
Proprietary Name: HYTONE
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080474
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DERMIK LABORATORIES DIV AVENTIS PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCORTISONE
Proprietary Name: HYTONE
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080474
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DERMIK LABORATORIES DIV AVENTIS PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: HYTONE
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: A080474
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DERMIK LABORATORIES DIV AVENTIS PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information