REDITREX (nda210737)- (7.5MG/0.3ML (7.5MG/0.3ML),10MG/0.4ML (10MG/0.4ML),12.5MG/0.5ML (12.5MG/0.5ML),15MG/0.6ML (15MG/0.6ML),17.5MG/0.7ML (17.5MG/0.7ML),20MG/0.8ML (20MG/0.8ML),22.5MG/ML (22.5MG/ML),25MG/1ML (25MG/1ML))

Generic Name	METHOTREXATE	Innovator	NORDIC GRP
Dosage	7.5MG/0.3ML (7.5MG/0.3ML),10MG/0.4ML (10MG/0.4ML),12.5MG/0.5ML (12.5MG/0.5ML),15MG/0.6ML (15MG/0.6ML),17.5MG/0.7ML (17.5MG/0.7ML),20MG/0.8ML (20MG/0.8ML),22.5MG/ML (22.5MG/ML),25MG/1ML (25MG/1ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	RediTrex is a folate analog metabolic inhibitor indicated for the: • Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

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
7.5MG/0.3ML (7.5MG/0.3ML)	**	**	-	-	-
10MG/0.4ML (10MG/0.4ML)	**	**	-	-	-
12.5MG/0.5ML (12.5MG/0.5ML)	**	**	-	-	-
15MG/0.6ML (15MG/0.6ML)	**	**	-	-	-
17.5MG/0.7ML (17.5MG/0.7ML)	**	**	-	-	-
20MG/0.8ML (20MG/0.8ML)	**	**	-	-	-
22.5MG/ML (22.5MG/ML)	**	**	-	-	-
25MG/1ML (25MG/1ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of REDITREX