APPLICATION
ANDA207957
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-26
LATEST ACTION
2019-11-27
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter
Products
FLUTICASONE PROPIONATEOver-the-counter
FLUTICASONE PROPIONATE 0.05MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-11-27Labeling · Supplement 4 · standardAP
2016-12-29Manufacturing (CMC) · Supplement 2 · unknownAP
2016-08-02Manufacturing (CMC) · Supplement 1 · unknownAP
2016-05-26UNKNOWN · Original · standardAP
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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