Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 008697

Expand all

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English