APPLICATION
NDA019621
TYPE
NDA
ORIGINAL APPROVAL
1987-06-10
LATEST ACTION
1998-09-18
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
VENTOLINDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
1998-09-18Labeling · Supplement 10 · standardAP
1997-10-30Labeling · Supplement 9 · standardAP
1995-01-26Manufacturing (CMC) · Supplement 7 · standardAP
1994-05-02Labeling · Supplement 5 · standardAP
1993-11-26Labeling · Supplement 4 · standardAP
1992-08-28Labeling · Supplement 3 · standardAP
1990-05-07Labeling · Supplement 2 · standardAP
1987-12-09Labeling · Supplement 1 · standardAP
1987-06-10Type 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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