APPLICATION
ANDA201528
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-27
LATEST ACTION
2024-05-15
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
2024-05-15Labeling · Supplement 8 · standardAP
2022-08-03Labeling · Supplement 6 · standardAP
2020-08-13Labeling · Supplement 5 · standardAP
2019-11-29Labeling · Supplement 3 · standardAP
2017-02-27UNKNOWN · 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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