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ORTIKOS (nda211929)- (6MG,9MG)

BUDESONIDE SUN PHARM INDS INC
6MG,9MG
No No
2036-Sep-09 Expired
None None
None No
ORTIKOS is a corticosteroid indicated for: • Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older. • Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.
0 0 0
Total Other Developers None
Drugs with Suitability No
6MG ** ** - - -
9MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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