APPLICATION
ANDA087858
TYPE
ANDA
ORIGINAL APPROVAL
1984-08-21
LATEST ACTION
1990-09-28
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
ISOETHARINE MESYLATEDiscontinued
ISOETHARINE MESYLATE 0.34MG/INH · AEROSOL, METERED · INHALATION
Approval history
1990-09-28Manufacturing (CMC) · Supplement 6AP
1989-05-19Manufacturing (CMC) · Supplement 5AP
1988-11-03Labeling · Supplement 4AP
1986-01-08Manufacturing (CMC) · Supplement 3AP
1986-01-08Manufacturing (CMC) · Supplement 2AP
1984-08-21OriginalAP
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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