APPLICATION
NDA018062
TYPE
NDA
ORIGINAL APPROVAL
1983-01-19
LATEST ACTION
1999-08-12
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROVENTIL · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
1999-08-12Manufacturing (CMC) · Supplement 19 · standardAP
1998-11-06Labeling · Supplement 16 · standardAP
1998-08-18Manufacturing (CMC) · Supplement 18 · standardAP
1996-09-09Manufacturing (CMC) · Supplement 15 · standardAP
1993-05-27Manufacturing (CMC) · Supplement 11 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 9 · standardAP
1986-11-19Manufacturing (CMC) · Supplement 7 · standardAP
1986-07-08Manufacturing (CMC) · Supplement 6 · standardAP
1985-05-16Labeling · Supplement 2 · standardAP
1985-05-16Manufacturing (CMC) · Supplement 1 · standardAP
1985-04-12Efficacy · Supplement 4 · standardAP
1984-12-04Manufacturing (CMC) · Supplement 5 · standardAP
1983-01-19Type 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.