APPLICATION
ANDA204639
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-23
LATEST ACTION
2024-07-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 250MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 140MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 20MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 180MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 100MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 5MG · CAPSULE · ORAL
Approval history
2024-07-15Labeling · Supplement 3 · standardAP
2022-01-26Labeling · Supplement 2 · standardAP
2020-08-13Labeling · Supplement 1 · standardAP
2016-11-23UNKNOWN · 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.
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.