Last Updated: September 28, 2026

Details for New Drug Application (NDA): 008697


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NDA 008697 describes CORTEF, which is a drug marketed by Pharmacia And Upjohn and is included in five NDAs. It is available from three suppliers. Additional details are available on the CORTEF profile page.

The generic ingredient in CORTEF is hydrocortisone acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for 008697
Tradename:CORTEF
Applicant:Pharmacia And Upjohn
Ingredient:hydrocortisone
Patents:0
Pharmacology for NDA: 008697
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Medical Subject Heading (MeSH) Categories for 008697
Anti-Inflammatory Agents
Suppliers and Packaging for NDA: 008697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORTEF hydrocortisone TABLET;ORAL 008697 NDA Pharmacia & Upjohn Company LLC 0009-0012 0009-0012-01 50 TABLET in 1 BOTTLE (0009-0012-01)
CORTEF hydrocortisone TABLET;ORAL 008697 NDA Pharmacia & Upjohn Company LLC 0009-0031 0009-0031-01 100 TABLET in 1 BOTTLE (0009-0031-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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