CORTEF (nda008697)- (5MG,10MG,20MG)

Generic Name	HYDROCORTISONE	Innovator	PHARMACIA AND UPJOHN
Dosage	5MG,10MG,20MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CORTEF Tablets are indicated in the following conditions: Endocrine Disorders, Rheumatic Disorders, Collagen Diseases, Dermatologic Diseases, Allergic States, Ophthalmic Diseases, Respiratory Diseases, Hematologic Disorders, Neoplastic Diseases, Edematous States, Gastrointestinal Diseases.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
5MG	**	**	-	-	3
10MG	**	**	-	-	3
20MG	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of CORTEF