APPLICATION
ANDA074749
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-30
LATEST ACTION
2017-09-25
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE/5ML · SYRUP · ORAL
Approval history
2017-09-25Manufacturing (CMC) · Supplement 10AP
2001-12-21Manufacturing (CMC) · Supplement 8AP
2001-12-21Manufacturing (CMC) · Supplement 6AP
2001-12-21Manufacturing (CMC) · Supplement 9AP
2001-12-21Manufacturing (CMC) · Supplement 7AP
2001-02-16Labeling · Supplement 5AP
1999-11-04Manufacturing (CMC) · Supplement 4AP
1999-11-04Manufacturing (CMC) · Supplement 2AP
1999-11-04Labeling · Supplement 3AP
1999-11-04Manufacturing (CMC) · Supplement 1AP
1998-01-30OriginalAP
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.