APPLICATION
ANDA072622
TYPE
ANDA
ORIGINAL APPROVAL
1992-09-30
LATEST ACTION
2000-08-28
ROUTE
INHALATION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETYLCYSTEINEDiscontinued
ACETYLCYSTEINE 20% · SOLUTION · INHALATION, ORAL
Approval history
2000-08-28Manufacturing (CMC) · Supplement 5AP
1999-05-25Labeling · Supplement 4AP
1998-04-13Manufacturing (CMC) · Supplement 3AP
1998-04-13Manufacturing (CMC) · Supplement 2AP
1996-08-28Manufacturing (CMC) · Supplement 1AP
1992-09-30OriginalAP
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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