APPLICATION
ANDA206309
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-27
LATEST ACTION
2024-07-15
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
2024-07-15Labeling · Supplement 4 · standardAP
2022-01-27Labeling · Supplement 1 · standardAP
2022-01-27Labeling · Supplement 2 · standardAP
2016-04-27UNKNOWN · 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.
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