APPLICATION
ANDA203691
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-08
LATEST ACTION
2025-07-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 180MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 100MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 5MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 250MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 140MG · CAPSULE · ORAL
TEMOZOLOMIDEPrescription
TEMOZOLOMIDE 20MG · CAPSULE · ORAL
Approval history
2025-07-01Labeling · Supplement 14 · standardAP
2022-01-26Labeling · Supplement 8 · standardAP
2019-07-16Labeling · Supplement 4 · standardAP
2016-01-12Labeling · Supplement 1 · standardAP
2015-05-08UNKNOWN · 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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