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TEMOZOLOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NIVAGEN PHARMS INC · Approved 2021-11-23

Drug application

FDA Application #

ANDA213328

Application type

Abbreviated New Drug Application (Generic)

Brand name

TEMOZOLOMIDE

Generic name

TEMOZOLOMIDE

Active ingredients

TEMOZOLOMIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Discontinued

Sponsor

NIVAGEN PHARMS INC

Manufacturer

Nivagen Pharmaceuticals, Inc.

First approval

2021-11-23

Source

Authoritative

Drugs@FDA application overview

Machine

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