APPLICATION
ANDA086899
TYPE
ANDA
ORIGINAL APPROVAL
1979-10-23
LATEST ACTION
1997-11-25
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ISOETHARINE HYDROCHLORIDEDiscontinued
ISOETHARINE HYDROCHLORIDE 1% · SOLUTION · INHALATION
Approval history
1997-11-25Manufacturing (CMC) · Supplement 13AP
1997-11-25Manufacturing (CMC) · Supplement 12AP
1996-08-28Manufacturing (CMC) · Supplement 11AP
1991-04-23Labeling · Supplement 10AP
1989-09-15Labeling · Supplement 9AP
1989-04-20Bioequivalence · Supplement 3AP
1989-01-24Manufacturing (CMC) · Supplement 6AP
1989-01-24Manufacturing (CMC) · Supplement 7AP
1982-09-10Manufacturing (CMC) · Supplement 2AP
1982-09-10Manufacturing (CMC) · Supplement 1AP
1979-10-23OriginalAP
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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