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FDA ANDA · ANDA208891

WIXELA INHUB

fluticasone propionate and salmeterol

Sponsor: MYLAN

APPLICATION
ANDA208891
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-30
LATEST ACTION
2022-03-31
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

WIXELA INHUBPrescription
FLUTICASONE PROPIONATE 0.5MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION
WIXELA INHUBPrescription
FLUTICASONE PROPIONATE 0.1MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION
WIXELA INHUBPrescription
FLUTICASONE PROPIONATE 0.25MG/INH, SALMETEROL XINAFOATE EQ 0.05MG BASE/INH · POWDER · INHALATION

Approval history

2022-03-31Labeling · Supplement 9 · standardAP
2019-01-30UNKNOWN · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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