APPLICATION
NDA019112
TYPE
NDA
ORIGINAL APPROVAL
1986-07-10
LATEST ACTION
1998-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VENTOLINDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET · ORAL
VENTOLINDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE · TABLET · ORAL
Approval history
1998-09-18Labeling · Supplement 14 · standardAP
1997-10-30Labeling · Supplement 13 · standardAP
1996-12-04Manufacturing (CMC) · Supplement 3 · standardAP
1995-01-26Manufacturing (CMC) · Supplement 11 · standardAP
1992-10-13Labeling · Supplement 7 · standardAP
1992-01-28Labeling · Supplement 6 · standardAP
1990-05-10Labeling · Supplement 4 · standardAP
1989-05-25Manufacturing (CMC) · Supplement 5 · standardAP
1988-06-02Manufacturing (CMC) · Supplement 1 · standardAP
1987-12-09Labeling · Supplement 2 · standardAP
1986-07-10Type 5 - New Formulation or New Manufacturer · 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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