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FDA NDA · NDA205636

PROAIR DIGIHALER

albuterol sulfate

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA205636
TYPE
NDA
ORIGINAL APPROVAL
2015-03-31
LATEST ACTION
2023-08-28
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER, METERED
MARKETING STATUS
Prescription, Discontinued

Products

PROAIR RESPICLICK · ReferencePrescription
ALBUTEROL SULFATE EQ 0.09MG BASE/INH · POWDER, METERED · INHALATION
PROAIR DIGIHALER · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 0.09MG BASE/INH · POWDER, METERED · INHALATION

Approval history

2023-08-28Labeling · Supplement 28 · standardAP
2022-01-27Labeling · Supplement 23 · standardAP
2020-09-29Labeling · Supplement 20 · standard — Letter ↗AP
2019-01-09Labeling · Supplement 12 · standard — Label ↗AP
2016-09-08Labeling · Supplement 6 · standard — Label ↗AP
2016-05-11Manufacturing (CMC) · Supplement 5 · standardAP
2016-04-28Efficacy · Supplement 4 · standard — Pediatric Medical Review ↗AP
2015-12-11Manufacturing (CMC) · Supplement 3 · standardAP
2015-07-30Manufacturing (CMC) · Supplement 2 · standardAP
2015-07-30Manufacturing (CMC) · Supplement 1 · standardAP
2015-03-31Type 3 - New Dosage Form · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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