MedPath
FDA Approval

YUPELRI

May 3, 2022

HUMAN PRESCRIPTION DRUG LABEL

Revefenacin(175 ug in 3 mL)

Products (1)

YUPELRI

49502-806

NDA210598

NDA (C73594)

RESPIRATORY (INHALATION)

May 3, 2022

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: G2AE2VE07OClass: ACTIBQuantity: 175 ug in 3 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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