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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 fifty-six 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 NDA: 008697

Tradename:
CORTEF
Applicant:
Pharmacia And Upjohn
Ingredient:
hydrocortisone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 008697

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 and Upjohn Company LLC 0009-0012 0009-0012-01 50 TABLET in 1 BOTTLE (0009-0012-01)
CORTEF
hydrocortisone
TABLET;ORAL 008697 NDA Pharmacia and Upjohn Company LLC 0009-0031 0009-0031-01 100 TABLET in 1 BOTTLE (0009-0031-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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