SUPRENZA (nda202088)- (15MG,30MG,37.5MG)

Generic Name	PHENTERMINE HYDROCHLORIDE	Innovator	CITIUS PHARMS
Dosage	15MG,30MG,37.5MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2029-Mar-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Suprenza 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
1	0	1

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
15MG	**	**	-	-	-
30MG	**	**	-	-	-
37.5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SUPRENZA