APPLICATION
ANDA087324
TYPE
ANDA
ORIGINAL APPROVAL
1981-04-08
LATEST ACTION
1996-08-28
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ISOETHARINE HYDROCHLORIDEDiscontinued
ISOETHARINE HYDROCHLORIDE 0.2% · SOLUTION · INHALATION
Approval history
1996-08-28Manufacturing (CMC) · Supplement 17AP
1992-01-27Labeling · Supplement 14AP
1991-03-15Labeling · Supplement 16AP
1990-10-12Labeling · Supplement 15AP
1990-02-16Labeling · Supplement 13AP
1989-01-17Labeling · Supplement 8AP
1988-12-19Bioequivalence · Supplement 5AP
1988-11-14Manufacturing (CMC) · Supplement 6AP
1988-11-14Manufacturing (CMC) · Supplement 7AP
1983-01-14Manufacturing (CMC) · Supplement 4AP
1981-04-08OriginalAP
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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