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FDA ANDA · ANDA214464
FLUTICASONE PROPIONATE AND SALMETEROL
Sponsor: RESPIRENT PHARMS
APPLICATION
ANDA214464
TYPE
ANDA
ORIGINAL APPROVAL
2026-01-12
LATEST ACTION
2026-01-12
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEPrescription
FLUTICASONE PROPIONATE 0.1MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEPrescription
FLUTICASONE PROPIONATE 0.25MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION
Approval history
2026-01-12UNKNOWN · 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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