FDA NDA · NDA208799

FLUTICASONE PROPIONATE AND SALMETEROL

Sponsor: TEVA PHARM

APPLICATION

NDA208799

TYPE

NDA

ORIGINAL APPROVAL

2017-01-27

LATEST ACTION

2023-11-16

ROUTE

RESPIRATORY (INHALATION), INHALATION

DOSAGE FORM

POWDER

MARKETING STATUS

Discontinued, Prescription

Products

AIRDUO DIGIHALER · ReferenceDiscontinued

FLUTICASONE PROPIONATE 0.113MG/INH, SALMETEROL XINAFOATE EQ 0.014MG BASE/INH · POWDER · INHALATION

AIRDUO RESPICLICK · ReferencePrescription

FLUTICASONE PROPIONATE 0.232MG/INH, SALMETEROL XINAFOATE EQ 0.014MG BASE/INH · POWDER · INHALATION

AIRDUO RESPICLICK · ReferencePrescription

FLUTICASONE PROPIONATE 0.055MG/INH, SALMETEROL XINAFOATE EQ 0.014MG BASE/INH · POWDER · INHALATION

AIRDUO DIGIHALER · ReferenceDiscontinued

FLUTICASONE PROPIONATE 0.232MG/INH, SALMETEROL XINAFOATE EQ 0.014MG BASE/INH · POWDER · INHALATION

AIRDUO DIGIHALER · ReferenceDiscontinued

FLUTICASONE PROPIONATE 0.055MG/INH, SALMETEROL XINAFOATE EQ 0.014MG BASE/INH · POWDER · INHALATION

AIRDUO RESPICLICK · ReferencePrescription

FLUTICASONE PROPIONATE 0.113MG/INH, SALMETEROL XINAFOATE EQ 0.014MG BASE/INH · POWDER · INHALATION

2023-11-16Labeling · Supplement 26 · standard — Letter ↗AP

2022-01-27Labeling · Supplement 19 · standard — Letter ↗AP

2021-07-09Efficacy · Supplement 21 · standard — Label ↗AP

2020-02-21Labeling · Supplement 11 · standard — Letter ↗AP

2018-03-02Labeling · Supplement 1 · standard — Label ↗AP

2017-12-20Labeling · Supplement 2 · standard — Label ↗AP

2017-01-27Type 4 - New Combination · Original · standard — Label ↗AP

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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