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OMONTYS PRESERVATIVE FREE (nda202799)- (EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML),EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML),EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML),EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML),EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML),EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML))

PEGINESATIDE ACETATE TAKEDA PHARMS USA
EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML),EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML),EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML),EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML),EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML),EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)
No No
2026-Jun-02 2017-Mar-27
None None
None No
OMONTYS is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) ** ** - - -
EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) ** ** - - -
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) ** ** - - -
EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) ** ** - - -
EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) ** ** - - -
EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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