AKLIEF (nda211527)- (0.005%)

Generic Name	TRIFAROTENE	Innovator	GALDERMA LABS LP
Dosage	0.005%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2033-May-30	NCE Excl Expiry	2024-Oct-04
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.005%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of AKLIEF