LOMOTIL (nda012462)- (0.025MG;2.5MG)

Generic Name	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	Innovator	PFIZER
Dosage	0.025MG;2.5MG
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	Lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	9

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
0.025MG;2.5MG	**	**	-	7	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	9

Manufacturing Details of LOMOTIL