APPLICATION
NDA017853
TYPE
NDA
ORIGINAL APPROVAL
1982-05-07
LATEST ACTION
1999-08-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROVENTIL · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PROVENTIL · ReferenceDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1999-08-12Manufacturing (CMC) · Supplement 20 · standardAP
1998-08-10Manufacturing (CMC) · Supplement 18 · standardAP
1996-09-09Manufacturing (CMC) · Supplement 15 · standardAP
1992-12-15Manufacturing (CMC) · Supplement 12 · standardAP
1989-01-24Manufacturing (CMC) · Supplement 10 · standardAP
1986-07-08Manufacturing (CMC) · Supplement 8 · standardAP
1986-03-16Manufacturing (CMC) · Supplement 3 · standardAP
1985-12-24Labeling · Supplement 7 · standardAP
1985-12-24Labeling · Supplement 6 · standardAP
1985-05-24Labeling · Supplement 1 · standardAP
1984-12-04Manufacturing (CMC) · Supplement 5 · standardAP
1982-05-07Type 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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