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FDA ANDA · ANDA203433

FLUTICASONE PROPIONATE AND SALMETEROL

Sponsor: HIKMA

APPLICATION
ANDA203433
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-17
LATEST ACTION
2023-12-19
ROUTE
RESPIRATORY (INHALATION), 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

2023-12-19Manufacturing (CMC) · Supplement 6 · unknownAP
2023-02-08Labeling · Supplement 3 · standardAP
2021-09-20Manufacturing (CMC) · Supplement 2 · unknown — Review ↗AP
2020-12-17UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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