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FDA ANDA · ANDA203959

TEMOZOLOMIDE

Sponsor: WATSON LABS TEVA

APPLICATION
ANDA203959
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-18
LATEST ACTION
2017-04-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 140MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 20MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 250MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 100MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 5MG · CAPSULE · ORAL

Approval history

2017-04-18UNKNOWN · OriginalAP
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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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