APPLICATION
NDA019489
TYPE
NDA
ORIGINAL APPROVAL
1988-05-04
LATEST ACTION
1999-06-30
ROUTE
INHALATION
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
VENTOLIN ROTACAPSDiscontinued
ALBUTEROL SULFATE EQ 0.2MG BASE · CAPSULE · INHALATION
Approval history
1999-06-30Manufacturing (CMC) · Supplement 19 · standardAP
1998-07-30Labeling · Supplement 18 · standardAP
1996-12-26Manufacturing (CMC) · Supplement 16 · standardAP
1995-01-26Manufacturing (CMC) · Supplement 13 · standardAP
1994-06-14Labeling · Supplement 12 · standardAP
1994-01-27Labeling · Supplement 11 · standardAP
1993-08-18Manufacturing (CMC) · Supplement 10 · standardAP
1993-07-20Efficacy · Supplement 8 · standardAP
1992-12-15Manufacturing (CMC) · Supplement 3 · standardAP
1992-10-28Labeling · Supplement 7 · standardAP
1992-05-21Labeling · Supplement 6 · standardAP
1992-04-06Manufacturing (CMC) · Supplement 5 · standardAP
1990-09-24Efficacy · Supplement 1 · standardAP
1990-09-24Labeling · Supplement 2 · standardAP
1988-05-04Type 3 - New Dosage Form · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.