WILPO (NDA012737)- (8MG)

Generic Name	PHENTERMINE HYDROCHLORIDE	Innovator	SANDOZ
Dosage	8MG
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	WILPO is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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
8MG	**	**	-	1	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of WILPO