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FDA ANDA · ANDA087396

ISOETHARINE HYDROCHLORIDE

Sponsor: ROXANE

APPLICATION
ANDA087396
TYPE
ANDA
ORIGINAL APPROVAL
1981-04-08
LATEST ACTION
1992-01-27
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ISOETHARINE HYDROCHLORIDEDiscontinued
ISOETHARINE HYDROCHLORIDE 0.1% · SOLUTION · INHALATION

Approval history

1992-01-27Labeling · Supplement 10AP
1991-03-15Labeling · Supplement 12AP
1990-03-22Labeling · Supplement 11AP
1981-04-08OriginalAP
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