Details for New Drug Application (NDA): 008697

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 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 008697

Tradename:	CORTEF
Applicant:	Pharmacia And Upjohn
Ingredient:	hydrocortisone
Patents:	0

Pharmacology for NDA: 008697

Mechanism of Action

Corticosteroid 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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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