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FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CIPLA · Approved 2026-07-27

Drug application

FDA Application #
ANDA213087
Application type
Abbreviated New Drug Application (Generic)
Brand name
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Generic name
FLUTICASONE PROPIONATE AND SALMETEROL
Active ingredients
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Dosage form
POWDER
Route
INHALATION
Marketing status
Prescription
Sponsor
CIPLA
Manufacturer
Cipla USA Inc.
First approval
2026-07-27

Source

Authoritative
Drugs@FDA application overview
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