APPLICATION
ANDA202610
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-29
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ISONIAZIDPrescription
ISONIAZID 300MG · TABLET · ORAL
ISONIAZIDPrescription
ISONIAZID 100MG · TABLET · ORAL
Approval history
2025-02-05Labeling · Supplement 1 · standardAP
2014-10-29UNKNOWN · 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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