APPLICATION
NDA019773
TYPE
NDA
ORIGINAL APPROVAL
1992-04-23
LATEST ACTION
1998-09-18
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
VENTOLIN · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
Approval history
1998-09-18Labeling · Supplement 10 · standardAP
1997-10-30Labeling · Supplement 9 · standardAP
1997-06-16Efficacy · Supplement 8 · standardAP
1995-01-26Manufacturing (CMC) · Supplement 5 · standardAP
1994-04-21Labeling · Supplement 4 · standardAP
1994-01-13Labeling · Supplement 2 · standardAP
1993-11-10Manufacturing (CMC) · Supplement 3 · standardAP
1992-04-23Type 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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