APPLICATION
ANDA089243
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-03
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
LANIAZIDDiscontinued
ISONIAZID 50MG/5ML · SYRUP · ORAL
Approval history
2025-02-05Labeling · Supplement 12 · standardAP
1990-01-09Labeling · Supplement 4AP
1987-09-09Manufacturing (CMC) · Supplement 2AP
1987-09-09Manufacturing (CMC) · Supplement 3AP
1987-09-09Manufacturing (CMC) · Supplement 1AP
1986-02-03OriginalAP
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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