← FDA DRUG APPROVALS

FDA NDA · NDA021747

COMBIVENT RESPIMAT

ipratropium bromide and albuterol

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA021747
TYPE
NDA
ORIGINAL APPROVAL
2011-10-07
LATEST ACTION
2020-09-27
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

COMBIVENT RESPIMAT · ReferencePrescription
ALBUTEROL SULFATE EQ 0.1MG BASE/INH, IPRATROPIUM BROMIDE 0.02MG/INH · SPRAY, METERED · INHALATION

Approval history

2020-09-27Labeling · Supplement 20 · standard — Letter ↗AP
2016-06-17Manufacturing (CMC) · Supplement 14 · standardAP
2016-06-09Labeling · Supplement 13 · standard — Letter ↗AP
2016-04-15Manufacturing (CMC) · Supplement 11 · standardAP
2016-01-29Labeling · Supplement 10 · standard — Letter ↗AP
2015-07-09Manufacturing (CMC) · Supplement 8 · standardAP
2015-03-09Manufacturing (CMC) · Supplement 7 · standardAP
2014-10-17Labeling · Supplement 5 · standard — Label ↗AP
2014-08-14Manufacturing (CMC) · Supplement 3 · standardAP
2014-06-19Manufacturing (CMC) · Supplement 4 · standardAP
2013-01-09Manufacturing (CMC) · Supplement 2 · standardAP
2012-08-29Labeling · Supplement 1 · unknown — Letter ↗AP
2011-10-07Type 3 - New Dosage Form · Original · standard — Review ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →