APPLICATION
ANDA071365
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-20
LATEST ACTION
2007-11-20
ROUTE
INHALATION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETYLCYSTEINEDiscontinued
ACETYLCYSTEINE 20% · SOLUTION · INHALATION, ORAL
Approval history
2007-11-20OriginalAP
2007-11-06Labeling · Supplement 12AP
2002-01-18Manufacturing (CMC) · Supplement 8AP
2002-01-18Labeling · Supplement 9AP
2001-09-17Manufacturing (CMC) · Supplement 7AP
2001-05-04Manufacturing (CMC) · Supplement 6AP
1998-11-18Manufacturing (CMC) · Supplement 4AP
1998-06-10Labeling · Supplement 5AP
1998-03-13Labeling · Supplement 3AP
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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