MedPath
FDA Approval

OTEZLA

February 5, 2021

HUMAN PRESCRIPTION DRUG LABEL

Products (3)

OTEZLA

59572-630

NDA205437

NDA (C73594)

ORAL

July 25, 2019

OTEZLA

59572-631

NDA205437

NDA (C73594)

ORAL

July 25, 2019

Code: UP7QBP99PNClass: ACTIBQuantity: 30.0 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

OTEZLA

59572-632

NDA205437

NDA (C73594)

ORAL

July 25, 2019

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