← FDA DRUG APPROVALS

FDA NDA · NDA208798

ARMONAIR RESPICLICK

Sponsor: TEVA PHARM

APPLICATION
NDA208798
TYPE
NDA
ORIGINAL APPROVAL
2017-01-27
LATEST ACTION
2023-11-16
ROUTE
INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

ARMONAIR RESPICLICK · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.055MG/INH · POWDER · INHALATION
ARMONAIR DIGIHALER · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.03MG/INH · POWDER · INHALATION
ARMONAIR DIGIHALER · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.232MG/INH · POWDER · INHALATION
ARMONAIR DIGIHALER · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.055MG/INH · POWDER · INHALATION
ARMONAIR RESPICLICK · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.113MG/INH · POWDER · INHALATION
ARMONAIR RESPICLICK · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.03MG/INH · POWDER · INHALATION
ARMONAIR DIGIHALER · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.113MG/INH · POWDER · INHALATION
ARMONAIR RESPICLICK · ReferenceDiscontinued
FLUTICASONE PROPIONATE 0.232MG/INH · POWDER · INHALATION

Approval history

2023-11-16Labeling · Supplement 16 · standard — Letter ↗AP
2022-04-08Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2022-01-27Labeling · Supplement 10 · standardAP
2021-07-09Efficacy · Supplement 8 · priority — Label ↗AP
2020-09-18Labeling · Supplement 7 · standard — Letter ↗AP
2018-03-02Labeling · Supplement 2 · standard — Label ↗AP
2017-01-27Type 5 - New Formulation or New Manufacturer · 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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