APPLICATION
ANDA072489
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-28
LATEST ACTION
2001-04-12
ROUTE
RESPIRATORY (INHALATION), INHALATION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ACETYLCYSTEINEPrescription
ACETYLCYSTEINE 10% · SOLUTION · INHALATION, ORAL
Approval history
2001-04-12Manufacturing (CMC) · Supplement 5AP
1999-11-04Manufacturing (CMC) · Supplement 2AP
1999-07-30Manufacturing (CMC) · Supplement 4AP
1998-09-23Labeling · Supplement 3AP
1998-03-13Labeling · Supplement 1AP
1995-07-28OriginalAP
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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