APPLICATION
NDA019383
TYPE
NDA
ORIGINAL APPROVAL
1987-07-13
LATEST ACTION
2001-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROVENTILDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-04-09Manufacturing (CMC) · Supplement 19 · standardAP
1999-05-24Manufacturing (CMC) · Supplement 9 · standardAP
1998-07-15Manufacturing (CMC) · Supplement 13 · standardAP
1997-12-12Manufacturing (CMC) · Supplement 3 · standardAP
1997-09-18Efficacy · Supplement 11 · standardAP
1996-09-09Manufacturing (CMC) · Supplement 8 · standardAP
1993-05-27Manufacturing (CMC) · Supplement 4 · standardAP
1992-06-05Manufacturing (CMC) · Supplement 2 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 1 · standardAP
1987-07-13Type 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.
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