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FDA NDA · NDA210598

YUPELRI

revefenacin

Sponsor: MYLAN IRELAND LTD

APPLICATION
NDA210598
TYPE
NDA
ORIGINAL APPROVAL
2018-11-09
LATEST ACTION
2022-05-25
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

YUPELRI · ReferencePrescription
REVEFENACIN 175MCG/3ML · SOLUTION · INHALATION

Approval history

2022-05-25Labeling · Supplement 3 · standard — Label ↗AP
2021-11-04Labeling · Supplement 2 · standard — Letter ↗AP
2019-05-21Labeling · Supplement 1 · standard — Letter ↗AP
2018-11-09Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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