APPLICATION
ANDA072324
TYPE
ANDA
ORIGINAL APPROVAL
1992-04-30
LATEST ACTION
2011-05-08
ROUTE
INHALATION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETYLCYSTEINEDiscontinued
ACETYLCYSTEINE 20% · SOLUTION · INHALATION, ORAL
Approval history
2011-05-08Labeling · Supplement 14AP
2001-04-03Manufacturing (CMC) · Supplement 5AP
2000-12-04Manufacturing (CMC) · Supplement 4AP
1996-06-18Manufacturing (CMC) · Supplement 3AP
1995-05-23Manufacturing (CMC) · Supplement 2AP
1992-04-30OriginalAP
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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