APPLICATION
ANDA091684
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-31
LATEST ACTION
2024-02-05
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ACETYLCYSTEINEPrescription
ACETYLCYSTEINE 6GM/30ML (200MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2024-02-05Labeling · Supplement 3 · standardAP
2020-12-17Labeling · Supplement 1 · standardAP
2017-10-31Not Applicable · OriginalAP
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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