← FDA DRUG APPROVALS
FDA ANDA · ANDA213087
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Sponsor: CIPLA
APPLICATION
ANDA213087
TYPE
ANDA
ORIGINAL APPROVAL
2026-07-27
LATEST ACTION
2026-07-27
ROUTE
INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEPrescription
FLUTICASONE PROPIONATE 0.5MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION
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
2026-07-27UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.