APPLICATION
ANDA088226
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-16
LATEST ACTION
1996-08-28
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ISOETHARINE HYDROCHLORIDEDiscontinued
ISOETHARINE HYDROCHLORIDE 0.167% · SOLUTION · INHALATION
Approval history
1996-08-28Manufacturing (CMC) · Supplement 9AP
1992-01-27Labeling · Supplement 7AP
1991-03-15Labeling · Supplement 8AP
1990-03-22Labeling · Supplement 6AP
1989-01-24Manufacturing (CMC) · Supplement 2AP
1989-01-24Manufacturing (CMC) · Supplement 3AP
1983-09-16OriginalAP
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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