Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008697

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CORTEF (HYDROCORTISONE)
5MG
Marketing Status: Prescription

Active Ingredient: HYDROCORTISONE
Proprietary Name: CORTEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N008697
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CORTEF (HYDROCORTISONE)
10MG
Marketing Status: Prescription

Active Ingredient: HYDROCORTISONE
Proprietary Name: CORTEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N008697
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information

CORTEF (HYDROCORTISONE)
20MG
Marketing Status: Prescription

Active Ingredient: HYDROCORTISONE
Proprietary Name: CORTEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N008697
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO
Marketing Status:  Prescription
Patent and Exclusivity Information