APPLICATION
NDA019243
TYPE
NDA
ORIGINAL APPROVAL
1987-01-14
LATEST ACTION
2001-04-09
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
PROVENTIL · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
PROVENTIL · 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ALBUTEROL SULFATE EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION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
2001-04-09Manufacturing (CMC) · Supplement 22 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 20 · standardAP
1998-11-06Labeling · Supplement 14 · standardAP
1996-09-09Manufacturing (CMC) · Supplement 13 · standardAP
1993-09-07Labeling · Supplement 10 · standardAP
1993-01-19Manufacturing (CMC) · Supplement 6 · standardAP
1992-12-15Manufacturing (CMC) · Supplement 9 · standardAP
1992-08-26Labeling · Supplement 8 · standardAP
1992-04-22Manufacturing (CMC) · Supplement 7 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 5 · standardAP
1988-11-21Manufacturing (CMC) · Supplement 4 · standardAP
1987-01-14Type 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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