APPLICATION
ANDA040648
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-05
LATEST ACTION
2025-02-05
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ISONIAZIDPrescription
ISONIAZID 100MG/ML · INJECTABLE · INJECTION
Approval history
2025-02-05Labeling · Supplement 24 · standardAP
2009-12-04Labeling · Supplement 5AP
2005-07-05OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.