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FDA NDA · NDA203108

STRIVERDI RESPIMAT

olodaterol respimat inhalation spray

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA203108
TYPE
NDA
ORIGINAL APPROVAL
2014-07-31
LATEST ACTION
2024-12-27
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

STRIVERDI RESPIMAT · ReferencePrescription
OLODATEROL HYDROCHLORIDE EQ 0.0025MG BASE/INH · SPRAY, METERED · INHALATION

Approval history

2024-12-27Labeling · Supplement 23 · standard — Letter ↗AP
2019-05-29Labeling · Supplement 8 · standard — Label ↗AP
2018-04-02Labeling · Supplement 6 · standard — Label ↗AP
2016-06-09Labeling · Supplement 3 · standard — Letter ↗AP
2014-07-31Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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