ORTHO-NOVUM 2-21 (nda012728)- (0.1MG;2MG)

Generic Name	MESTRANOL; NORETHINDRONE	Innovator	ORTHO MCNEIL PHARM
Dosage	0.1MG;2MG
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	ORTHO-NOVUM® Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.1MG;2MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ORTHO-NOVUM 2-21