APPLICATION
ANDA208166
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-20
LATEST ACTION
2024-03-04
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ACETYLCYSTEINEPrescription
ACETYLCYSTEINE 6GM/30ML (200MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2024-03-04Labeling · Supplement 4 · standardAP
2024-03-04Labeling · Supplement 1 · standardAP
2018-07-20UNKNOWN · Original · standardAP
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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