APPLICATION
ANDA073664
TYPE
ANDA
ORIGINAL APPROVAL
1994-08-30
LATEST ACTION
2016-01-15
ROUTE
ORAL, RESPIRATORY (INHALATION), INHALATION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ACETYLCYSTEINEPrescription
ACETYLCYSTEINE 10% · SOLUTION · INHALATION, ORAL
Approval history
2016-01-15Labeling · Supplement 18 · standardAP
1998-08-05Labeling · Supplement 6AP
1996-02-05Manufacturing (CMC) · Supplement 3AP
1996-02-05Manufacturing (CMC) · Supplement 1AP
1996-02-05Labeling · Supplement 4AP
1996-02-05Manufacturing (CMC) · Supplement 2AP
1994-08-30OriginalAP
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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