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FDA ANDA · ANDA201742

TEMOZOLOMIDE

Sponsor: SUN PHARM

APPLICATION
ANDA201742
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-12
LATEST ACTION
2026-01-22
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

2026-01-22Labeling · Supplement 20 · standardAP
2026-01-22Labeling · Supplement 21 · standardAP
2021-06-25Labeling · Supplement 13 · standardAP
2021-06-25Labeling · Supplement 16 · standardAP
2019-11-29Labeling · Supplement 11 · standardAP
2017-09-22Labeling · Supplement 10 · standardAP
2015-11-09Labeling · Supplement 7 · standardAP
2015-06-10Labeling · Supplement 5 · standardAP
2015-01-05Labeling · Supplement 1 · standardAP
2014-02-12Not Applicable · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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