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OTREXUP (nda204824)- (7.5MG/0.4ML (7.5MG/0.4ML),10MG/0.4ML (10MG/0.4ML),12.5MG/0.4ML (12.5MG/0.4ML),15MG/0.4ML (15MG/0.4ML),17.5MG/0.4ML (17.5MG/0.4ML),20MG/0.4ML (20MG/0.4ML),22.5MG/0.4ML (22.5MG/0.4ML),25MG/0.4ML (25MG/0.4ML))

METHOTREXATE OTTER PHARMS
7.5MG/0.4ML (7.5MG/0.4ML),10MG/0.4ML (10MG/0.4ML),12.5MG/0.4ML (12.5MG/0.4ML),15MG/0.4ML (15MG/0.4ML),17.5MG/0.4ML (17.5MG/0.4ML),20MG/0.4ML (20MG/0.4ML),22.5MG/0.4ML (22.5MG/0.4ML),25MG/0.4ML (25MG/0.4ML)
No Yes
2031-May-27 Expired
None None
None No
Otrexup 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.
0 0 0
Total Other Developers None
Drugs with Suitability No
7.5MG/0.4ML (7.5MG/0.4ML) ** ** - - -
10MG/0.4ML (10MG/0.4ML) ** ** - - -
12.5MG/0.4ML (12.5MG/0.4ML) ** ** - - -
15MG/0.4ML (15MG/0.4ML) ** ** - - -
17.5MG/0.4ML (17.5MG/0.4ML) ** ** - - -
20MG/0.4ML (20MG/0.4ML) ** ** - - -
22.5MG/0.4ML (22.5MG/0.4ML) ** ** - - -
25MG/0.4ML (25MG/0.4ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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