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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 008917


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NDA 008917 describes CORTEF ACETATE, which is a drug marketed by Pharmacia And Upjohn and is included in two NDAs. Additional details are available on the CORTEF ACETATE profile page.

The generic ingredient in CORTEF ACETATE is hydrocortisone acetate. There are sixty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for 008917
Tradename:CORTEF ACETATE
Applicant:Pharmacia And Upjohn
Ingredient:hydrocortisone acetate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrength2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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