PREDNISONE (nda017109)- (20MG)

Generic Name	PREDNISONE	Innovator	ROXANE
Dosage	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	Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders 2. Rheumatic Disorders 3. Collagen Diseases 4. Dermatologic Diseases 5. Allergic States 6. Ophthalmic Diseases 7. Respiratory Diseases 8. Hematologic Disorders 9. Neoplastic Diseases 10. Edematous States 11. Gastrointestinal Diseases 12. Nervous System and other Miscellaneous.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	33

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

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

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PREDNISONE