← FDA DRUG APPROVALS

FDA ANDA · ANDA087907

EPINEPHRINE

Sponsor: ARMSTRONG PHARMS

APPLICATION
ANDA087907
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-23
LATEST ACTION
2010-03-25
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued

Products

EPINEPHRINEDiscontinued
EPINEPHRINE 0.2MG/INH · AEROSOL, METERED · INHALATION

Approval history

2010-03-25Labeling · Supplement 38AP
2009-06-12Labeling · Supplement 34AP
2008-05-09Labeling · Supplement 24AP
2002-07-09Labeling · Supplement 20AP
2001-12-04Manufacturing (CMC) · Supplement 19AP
1995-05-04Labeling · Supplement 18AP
1993-07-28Labeling · Supplement 17AP
1993-02-26Manufacturing (CMC) · Supplement 15AP
1993-02-26Manufacturing (CMC) · Supplement 13AP
1993-02-26Manufacturing (CMC) · Supplement 14AP
1993-02-26Manufacturing (CMC) · Supplement 12AP
1991-02-15Labeling · Supplement 10AP
1990-10-25Labeling · Supplement 11AP
1990-09-28Manufacturing (CMC) · Supplement 16AP
1990-05-16Manufacturing (CMC) · Supplement 6AP
1990-05-16Labeling · Supplement 7AP
1989-10-02Labeling · Supplement 2AP
1984-05-23OriginalAP
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 →