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It is approved under NDA 21-395 for HandiHaler Jan 30 2004 and NDA 21936 for Respimat Sep 24 2014. 0 mcg of and 5. 0 mcg olodaterol. 13. ROUTE OF ADMINSITRATION Oral inhalation 14. Rx/OTC DISPENSED Rx OTC 15. Ingredients as follow. Acceptable. These were evaluated and considered adequate during the reviews for NDA 21-936 Respimat 2014 and NDA 203-108 Striverdi Respimat 2014. The above NDA is cross-referenced to this NDA. Olodaterol drug substance was considered NME during the NDA submission...
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