APPLICATION
NDA019269
TYPE
NDA
ORIGINAL APPROVAL
1987-01-16
LATEST ACTION
1998-09-18
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
VENTOLINDiscontinued
ALBUTEROL SULFATE EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
Approval history
1998-09-18Labeling · Supplement 16 · standardAP
1997-10-30Labeling · Supplement 15 · standardAP
1997-06-16Efficacy · Supplement 14 · standardAP
1995-01-26Manufacturing (CMC) · Supplement 11 · standardAP
1992-08-05Manufacturing (CMC) · Supplement 7 · standardAP
1992-07-21Manufacturing (CMC) · Supplement 5 · standardAP
1992-07-21Labeling · Supplement 8 · standardAP
1992-07-21Manufacturing (CMC) · Supplement 4 · standardAP
1989-03-16Manufacturing (CMC) · Supplement 3 · standardAP
1987-01-16Type 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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