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An application for orphan drug designation may be submitted at the same time as the PA determination request, if the product fulfils the orphan drug criteria [23, 24]
Transdermal and Inhalation Methods Transdermal patches/creams: Applied once or twice daily
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Band intensities were quantified by densitometric analysis using ImageJ software (National Institutes of Health, Bethesda, MD, USA), and all results were normalized to -actin
Manufactured in an FDA Registered Facility using Good Manufacturing Practices(GMPs) *This statement has not been evaluated by the Food and Drug Administration
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