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OTEZLA (nda205437)- (10MG,20MG,30MG)

APREMILAST AMGEN INC
10MG,20MG,30MG
Yes No
2034-Nov-29 2019-Mar-21
None None
None No
OTEZLA, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: • Adult patients with active psoriatic arthritis • Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy • Adult patients with oral ulcers associated with Behçet’s Disease
9 5 0
Total Other Developers 11
Drugs with Suitability No
10MG ** ** - - -
20MG ** ** - - -
30MG ** ** Up - -
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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