APPLICATION
NDA009410
TYPE
NDA
ORIGINAL APPROVAL
1954-09-21
LATEST ACTION
1998-05-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOTUSATEDiscontinued
TALBUTAL 120MG · TABLET · ORAL
Approval history
1998-05-12Labeling · Supplement 5AP
1998-05-12Labeling · Supplement 3AP
1985-10-29Labeling · Supplement 8AP
1982-03-15Labeling · Supplement 7AP
1980-04-02Labeling · Supplement 6AP
1954-09-21Type 1 - New Molecular Entity · 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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