← FDA DRUG APPROVALS

FDA ANDA · ANDA213328

TEMOZOLOMIDE

Sponsor: NIVAGEN PHARMS INC

APPLICATION
ANDA213328
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-23
LATEST ACTION
2021-11-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 250MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 140MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 20MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 180MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 100MG · CAPSULE · ORAL
TEMOZOLOMIDEDiscontinued
TEMOZOLOMIDE 5MG · CAPSULE · ORAL

Approval history

2021-11-23UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →